Systems for forming an anastomosis

ABSTRACT

Compression plate apparatus enables vessels to be joined together in various anastomosis configurations. The compression plates are guided to each other in a parallel orientation by guides. The compression plate apparatus may be utilized with an intraluminally directed anvil apparatus or an externally positioned anvil apparatus. One of the compression plates assists in the eversion of the anastomosis fenestra contour. One of the compression plates enables a graft vessel to be pre-everted so that the anastomosis fenestra contours are everted. The apparatus provides a structure that enables the vessels to be joined without being penetrated.

RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.09/737,200, entitled Compression Plate Anastomosis Apparatus and RelatedSystems, filed Dec. 14, 2000; U.S. application Ser. No. 09/737,200 is acontinuation-in-part of U.S. application Ser. No. 09/460,740, entitledCompression Plate Anastomosis Apparatus, filed Dec. 14, 1999, now U.S.Pat. No. 6,569,173, and is also a continuation-in-part of U.S.application Ser. No. 09/293,617, entitled Anastomosis Apparatus For Usein Intraluminally Directed Vascular Anastomosis, filed Apr. 16, 1999,now U.S. Pat. No. 6,248,117. Each of the foregoing applications isincorporated herein by specific reference.

BACKGROUND

1. The Field of the Invention

The present invention is directed generally to anastomosis methods,systems and devices. More specifically the present invention is directedto compression plate vascular anastomosis methods, systems and deviceswith the use of a vascular anvil.

2. Relevant Technology

Additional aspects and advantages will be apparent from the followingdetailed description of preferred embodiments, which proceeds withreference to the accompanying drawings.

Endoscopic applications are generally used in intracavity proceduressuch as intrathoracic and intraabdominal procedures. Peripheraltechniques are usually employed in other body regions, such as arms andlegs. It is desirable to be able to provide by active endoscopic orperipheral procedures a variety of medical services that are currentlyprovided by techniques that are more invasive and more demanding in timeand in medical resources and skills. This goal is justified by theefficiency, effectiveness, safety, low cost, and preventiveaccomplishments of active endoscopic or peripheral procedures. Inparticular, this invention provides new methods, devices and systems forperforming vascular anastomoses by intraluminally directed activeendoscopic or peripheral procedures. The intraluminally directed orintravascular part of the procedures of this invention is based on anexamination performed by, for example, fluoroscopy, and extraluminalmanipulation is performed endoscopically or according to a peripheraltechnique.

One aspect of this invention encompasses the quasi-simultaneity of theexploration, diagnosis and corrective tasks that can be achieved invascular anastomoses performed by the active endoscopic or peripheralprocedures of this invention. Another aspect of this invention includesthe minimally invasive character of the vascular anastomoses that areperformed by the active endoscopic or peripheral procedures of thisinvention. These procedures are also characterized by comparativelyreduced requirements of medical facilities and skill. To moreeffectively describe and enable the present invention, a review of somebasic terminology and related technology is offered in the immediatelyfollowing subsections.

2.1. Terminology

An anastomosis is an operative union of two hollow or tubularstructures. Anastomotic structures can be part of a variety of systems,such as the vascular system, the digestive system or the genitourinarysystem. For example, blood is shunted from an artery to a vein in anarteriovenous anastomosis, and from the right pulmonary artery to thesuperior vena cava in a cavopulmonary anastomosis. In other examples,afferent and efferent loops of jejunum are joined in a Braun'sanastomosis after gastroenteroscopy; the ureter and the Fallopian tubeare joined in a ureterotubal anastomosis, and the ureter and a segmentof the sigmoid colon are joined in a ureterosigmoid anastomosis. Inmicrovascular anastomosis, very small blood vessels are anastomosedusually under surgical microscope.

An anastomosis is termed end-to-end when the terminal portions oftubular structures are anastomosed, and it is termed end-to-side whenthe terminal portion of a tubular structure is anastomosed to a lateralportion of another tubular or hollow structure. In an end-to-sideanastomosis, we often refer to the structure whose end is anastomosed asthe “graft vessel” while the structure whose side wall is anastomosed isreferred to as the “receiving structure”.

Anastomotic material typically includes autologous material, but it canalso include heterologous material or synthetic material. An autologousgraft is a graft in which the donor and recipient areas are in the sameindividual. Heterologous material is derived from an animal of adifferent species. The graft can be made of a synthetic material such asexpanded polytetrafluoroethylene (“ePTFE”). Wolf Dieter Brittinger,Gottfried Walker, Wolf-Dieter Twittenhoff, and Norbert Konrad, VascularAccess for Hemodialysis in Children, Pediatric Nephrology, Vol. 11(1997) pp. 87-95.

A nonocclusive anastomosis is typically an end-to-side anastomosis inwhich the flow of matter through the vessel that is anastomosed in itsside is not interrupted while the anastomosis is performed. Mostconventional techniques for vascular anastomosis require theinterruption of blood flow through the receiving vessel while theanastomosis is performed.

Although the parts of a blood vessel are designated by well-known termsin the art, a few of these parts are briefly characterized here forintroducing basic terminology. A blood vessel is in essence a tubularstructure. In general, the region comprised within tubular walls, suchas those defining a blood vessel or the walls defining the tubularmember of an endoscope, is termed the lumen or the intraluminal space. Alumen that is not occluded is a patent lumen and the higher the patencyof a blood vessel, the less disrupted the blood flow through such vesselis. A reduction of a blood vessel's patency can be caused by a stenosis,which is generally a stricture or narrowing of the blood vessel's lumen.A hyperplasia, or tissue growth, can also reduce a blood vessel'spatency. Reduction of blood vessel patency, and in general a disruptionin a vessel's blood flow, can lead to ischemia, which is a local lack ofoxygen in tissue due to a mechanical obstruction of the blood supply.

A stent is a device that can be used within the lumen of tubularstructures to assure patency of an intact but contracted lumen.Placement of a stent within an occluded blood vessel is one way ofperforming an angioplasty, which is an operation for enlarging anarrowed vascular lumen. Angioplasty and bypass are different ways forreestablishing blood supply, an operation that is calledrevascularization.

A blood vessel is composed of three distinct layers. From inside tooutside, these layers include the intima, the media and the adventitia.The intima is a single layer of flat cells that collectively line thelumen. The media is a thick middle layer composed of smooth musclecells. The adventitia is an outer layer that comprises fibrous covering.

Angiography is a technique for performing a radiograph of vessels afterthe injection of a radio-opaque contrast material. This techniqueusually requires percutaneous injection of a radio-opaque catheter andpositioning under fluoroscopic control. An angiogram is a radiographobtained by angiography. Fluoroscopy is an examination technique with anapparatus, the fluoroscope, that renders visible the patterns of X-rayswhich have passed through a body under examination.

2.2 Related Technology

The operative union of two hollow or tubular structures requires thatthe anastomosis be tight with respect to the flow of matter through suchstructures and also that the anastomosed structures remain patent forallowing an uninterrupted flow of matter therethrough. For example,anastomosed blood vessels should not leak at the anastomosis site, theanastomotic devices should not significantly disrupt the flow of blood,and the anastomosis itself should not cause a biological reaction thatcould lead to an obstruction of the anastomosed blood vessels. Inparticular, anastomosed blood vessels should remain patent and theyshould ideally not develop hyperplasia, thrombosis, spasms orarteriosclerosis.

Because anastomosed structures are composed of tissues that aresusceptible to damage, the anastomosis should furthermore not besignificantly detrimental to the integrity of these tissues. Forexample, injury to endothelial tissue and exposure of subintimalconnective tissue should be minimized or even eliminated in vascularanastomosis.

Because structures to be anastomosed are internal, an anastomosisrequires a degree of invasion. The invasive character of an anastomosis,however, should be minimized subject to the reliable performance of asatisfactory anastomosis. Accordingly, there has been a noticeable trendduring the last quarter of this century towards less invasive surgicalintervention, a surgical style that is termed minimally invasivesurgery. This style is characterized by pursuing a maximal treatmenteffect with minimal damage to surrounding and overlying normalstructures. In addition, successful minimally invasive procedures shouldprocure patency and they should minimize damage to the tissues of theanastomosed structures themselves.

A plurality of factors provide a propitious environment for this trendtowards minimally invasive surgery. These factors include thedevelopment of high-technology diagnostic devices, the innatecharacteristics of human psychology and economic imperatives.

High-technology diagnostic devices such as flexible fiber-opticendoscopes and intravascular catheters have considerably enhanced ourability for performing a reliable spacio-temporal location of disease.More specifically, these devices permit the early and accuratedetermination of disease processes and their loci. Furthermore, it isknown that the earlier a tumor or growth can be identified, the moreresponsive it is to therapy by a minimally invasive technique. SeeRodney Perkins, Lasers in Medicine in Lasers—invention to Application,edited by John R. Whinnery, Jesse H. Ausubel, and H. Dale Langford, p.104, National Academy of Engineering, National Academy Press,Washington, D.C. 1987. (This article will hereinafter be referred to as“Lasers—Invention to Application”). See also Edward R. Stephenson,Sachin Sankholkar, Christopher T. Ducko, and Ralph J. Damiano,Robotically Assisted Microsurgery for Endoscopic Coronary Artery BypassGrafting, Annals of Thoracic Surgery, Vol. 66 (1998) p. 1064. (Thisarticle will hereinafter be referred to as “Endoscopic Coronary ArteryBypass Grafting”).

Human psychology also contributes to the growing trend towards minimallyinvasive techniques. This is attributed to the accepted prevailingpreference of a minimally invasive technique with respect to a moreinvasive surgical technique whenever the outcomes of these twotechniques are equivalent.

Finally, minimally invasive techniques are generally cost effective toinsurers and to society in general because they are performed on anoutpatient basis or else they require comparatively shorterhospitalization time. Furthermore, the less tissue is invasivelyeffected in a procedure, the more likely it is that the patient willrecover in a comparatively shorter period of time with lower costhospitalization. Therefore, economic factors also favor the developmentof minimally invasive techniques because they can be performed withlower morbidity risk and they satisfy economic imperatives such asreduced cost and reduced loss of productive time. See Rodney Perkins inLasers—Invention to Application, p. 104; Endoscopic Coronary ArteryBypass Grafting, pp. 1064, 1067.

Particularly in the field of vascular anastomosis, it is acknowledgedthat there is an increasing demand for an easier, quicker, lessdamaging, but reliable procedure to create vascular anastomosis. Thisdemand is further revitalized by the movement of vascular procedurestowards minimally invasive procedures. See Paul M. N. Werker and MosheKon, Review of Facilitated Approaches to Vascular Anastomosis Surgery,Annals of Thoracic Surgery, Vol. 63 (1997) pp. S122-S127. (This workwill hereinafter be referred to as “Review of Facilitated Approaches toVascular Anastomosis”).

Conventional exploration and anastomosis techniques are not alwaysimplemented in such a way as to satisfy the demand for an easier,quicker, less damaging, but reliable vascular anastomosis. The followingoverview of conventional exploration and anastomosis techniques closesthis background section on related technology.

Exploration of a blood vessel typically provides necessary informationfor locating and diagnosing vascular abnormalities such as those thatreduce vascular patency. This exploration can rely on examinationtechniques such as angiography and endoscopy. Vascular abnormalities areusually detected fluoroscopically according to an angiography procedure.When it is concluded that the appropriate corrective action requires ananastomosis, conventional procedures ordinarily follow a sequence inwhich the anastomosis is not performed at the time when the initialexploration and diagnostic are performed, but at a later time and in atypically different clinical setup. Accordingly, the time and resourcesthat are spent during the exploration and diagnostic phases are notdirectly employed in the performance of an appropriate correctiveaction, such as an anastomosis.

By performing an anastomosis considerably after the initial explorationhas taken place and in a different location and clinical environment,these conventional procedures also waste a significant part of theinformation acquired at the exploration phase. Images obtained during anangiographic procedure are typically recorded on film or digital medium.In current clinical practice, these recorded images are reviewed in asubsequent clinical setting and based upon a knowledge of externalanatomy, the lesion location and optimal site for anastomosis areestimated. This process sacrifices potentially useful information.Fluoroscopic visualization is no longer available without repeating theangiogram procedure, and in conventional practice external anatomiclocalization is used in correlation with previously recorded images. Inaddition to this external inspection, conventional procedures could relyon imaging for determining the optimal anastomosis site when correctiveaction is taken. However, having to reacquire information leads to awaste of resources, it significantly increases the period of time fromexploration to corrective action, it is an additional burden on thepatient, and it enhances the invasive character of the treatment that isadministered to the patient. Furthermore, reacquisition of informationmight have to be done in an environment that demands higher skills andmore resources than they would have been otherwise needed. For example,the opening of a body cavity to expose the anatomical region around apotential anastomosis site, the determination of the optimal anastomosissite by external inspection, and the surgical performance of theanastomosis are part of a treatment that is more complex, requirespractitioners with more training, and may be more time and resourceconsuming than the treatment provided by the methods, systems andapparatuses of the present invention.

Vascular anastomosis techniques can be classified in a plurality ofgroups. Although with various degrees of success, all these techniquesgenerally intend to provide leak-proof joints that are not susceptibleto mechanical failure, and they also intend to minimize damage andreduce the undesirable effects of certain operational features that maylead to post-anastomosis complications. Damage to be minimized andoperational features whose undesirable effects should be reduced includeendothelial coverage injury, exposure of subintimal connective tissue,exposure of an intraluminal foreign component, blood flow interruption,irregularities at the junction, adventitial tissue stripping, intimalinjury, installment of a foreign rigid body, use of materials that mayhave toxic effects, damage to surrounding tissue, extensive vesseleversion, and tissue plane malalignment. Post-anastomosis complicationsinclude intimal hyperplasia, atherosclerosis, thrombosis, stenosis,tissue necrosis, vascular wall thinning, and aneurism formation. Inaddition, vascular anastomosis techniques are characterized by varyingabilities to successfully cope with the dilating character of thestructures to be anastomosed, their diversity in size, and thepossibility that at least one structure may grow after the anastomosishas been performed. Other variables that partially determine thesuitability of a specific anastomosis technique include the nature ofthe material to be anastomosed (for example, autologous, heterologous,or synthetic), the desired reduction in operative time, the skillrequirements, and the healing time.

Each one of the techniques discussed hereinbelow for joining anastomosedstructures presents a compromise for reducing undesirable effects in thepractice of vascular anastomosis. High standards in one or a few aspectsof the anastomosis can sometimes be achieved only at the expense ofsacrificing what otherwise would have been the benefits of other aspectsof the anastomosis.

Since early in the 20th century when vessel anastomoses were performedwith an acceptable degree of reliability, the standard for creation of avascular anastomosis has been manual suturing. Review of FacilitatedApproaches to Vascular Anastomosis, p. S122. Suturing devices andmethods are still being developed with the aim at performing lessinvasive surgical procedures within a body cavity. See, for example,U.S. Pat. No. 5,860,992 disclosing devices and methods for sutureplacement while performing less invasive procedures.

Regarding the application of sutures in vascular anastomoses, it hasbeen generally reported that “the insertion of transmural stitches, evenin experienced hands that employ a traumatic techniques and finesutures, causes significant damage to the vessel wall. As the result ofthis the subendothelial matrix becomes exposed to the bloodstream andinitiates the formation of a thrombus. The same process takes place atthe actual site of the anastomosis in the case of intima-intimaapposition. These processes are multifactorial but can cause obstructionof the complete anastomosis, especially in small vessels.” Review ofFacilitated Approaches to Vascular Anastomosis, p. S122. In addition toproximal occlusion, needle-and-suture-mediated intimal penetration isbelieved to represent a source of platelet emboli, which can causedistal embolization and thus a hazard in brain revascularization andmyocardial circulation. Patrick Nataf, Wolff Kirsch, Arthur C. Hill,Toomas Anton, Yong Hua Zhu, Ramzi Ramadan, Leonardo Lima, Alain Pavie,Christian Cabrol, and Iradj Gandjbahch, Nonpenetrating Clips forCoronary Anastomosis, Annals of Thoracic Surgery, Vol. 63 (1997) p.S137. (This article will hereinafter be referred to as “NonpenetratingClips for Coronary Anastomosis”). Furthermore, it is considered that“suture anastomosis of small vessels is time-consuming and tedious anddemands a long and continuous training if high patency rates are to beregularly achieved.” Willy D. Boeckx, Oliskevigius Darius, Bert van denhof, and Carlo van Holder, Scanning Electron Microscopic Analysis of theStapled Microvascular Anastomosis in the Rabbit, Annals of ThoracicSurgery, Vol. 63 (1997) p. S128. (This work will hereinafter be referredto as “Microscopic Analysis of Stapled Microvascular Anastomosis”). Incontrast, in all specialties that employ vascular surgery, “there is anincreasing demand for a simple, time-saving, but reliable automated,semiautomated, or at least facilitated method to replace the process ofmanually sutured anastomosis. The most important reason for this demandis the movement of cardiac bypass surgery toward a minimally invasiveand possibly even an endoscopic procedure.” Review of FacilitatedApproaches to Vascular Anastomosis, p. S122. In this respect,improvement “may come from techniques that do not lead to exposure of[a] damaged vessel wall to the bloodstream” Id., p. S122.

Besides the group that includes techniques which rely on suturing,vascular anastomosis techniques can generally be classified in fourgroups depending on how the tissue is joined and on the type of deviceor material used for joining the tissue of the anastomosed vessels.These groups are: Stapling and clipping techniques, coupling techniques,pasting techniques, and laser techniques. Id., pp. S122-S127.

2.2.1. Stapling and Clipping Techniques

Although some staplers have been reported as providing leaky joints, avariety of staplers have been developed for end-to-end and forend-to-side anastomosis. U.S. Pat. No. 5,366,462 discloses a method ofend-to-side vascular anastomosis. According to this method, the end ofthe graft blood vessel that is to be anastomosed is everted by180.degree.; one end of the staple pierces both vessels with puncturesexposed to the blood flow and the other end of the staple pierces theoutside of the receiving vessel. U.S. Pat. No. 5,732,872 discloses asurgical stapling instrument that comprises an expandable anvil foraiding in the stapling of a 180.degree. everted end of a graft vessel toa receiving vessel. This patent also discloses a stapling instrument forjoining the 180.degree. everted second end of a graft vessel whoseopposite end has already been anastomosed. To anastomose this secondend, this technique requires clearance around the area in which theanastomosis is performed, exposure of the receiving blood vessel,external anatomic identification, and significant external manipulationin the open area around the anastomosis site. U.S. Pat. No. 4,930,674discloses methods of end-to-end and end-to-side anastomosis and asurgical stapler that comprises a vessel gripping structure for joiningthe 180.degree. everted end of a graft vessel to another vessel. U.S.Pat. No. 5,695,504 discloses methods and a system for performing anend-to-side vascular anastomosis, where the system is applicable forperforming an anastomosis between a vascular graft and the ascendingaorta in coronary artery bypass surgery, particularly in port-accesscoronary artery bypass graft surgery. This system includes a staple witha configuration that combines the functions of an anchor member and acoupling member into a one-piece anastomosis staple. U.S. Pat. No.5,861,005 discloses an arterial stapling method and device for staplingan opening in an anatomical structure, whether the opening isdeliberately formed or accidentally caused. This device employs aballoon catheter that helps positioning the stapling mechanism properlyon the organ to be stapled.

Some stapling devices rely on access to the anastomosis area through anopening that might be as big as or comparable to typical openings thatare required in surgical procedures. Furthermore, the 180.degree.eversion of vessel ends is viewed as an operation that can be difficult,particularly in sclerotic vessels. Review of Facilitated Approaches toVascular Anastomosis, p. S123.

In general, clipping techniques rely on arcuate legged clips forachieving a flanged, nonpenetrated, intimal approximation of theanastomosed structures. Reportedly, the use of s clips leads to abiologically and technically superior anastomosis as compared to thepenetrating microsuture. Review of Facilitated Approaches to VascularAnastomosis, p. S123. By approximating the everted walls of the twovessels to be anastomosed, a clipping technique avoids stitching andreportedly the subsequent risk of intimal hyperplasia. Gianfranco Lisi,Louis P. Perrault, Philippe Menasche, Alain Bel, Michel Wassef,Jean-Paul Vilaine, and Paul M. Vanhoutte, Nonpenetrating Stapling: AValuable Alternative to Coronary Anastomoses, Annals of ThoracicSurgery, Vol. 66 (1998) p. 1707. In addition, maintenance of anuninjured endothelial coverage and avoidance of exposure of subintimalconnective tissue are considered important features because “regeneratedendothelium presents selective dysfunction that may predispose to spasmand atherosclerosis, thereby affecting both medium-term and long-termgraft patency” and the risk of thrombosis at the anastomotic site can bereduced. Id., p. 1707.

Nonpenetrating vascular closure staples (“VCS”) have been used inanastomoses performed to provide access for dialysis, as well as inkidney and pancreas transplantation. It has been concluded in light ofthese anastomoses that “the fact that VCS staples are interrupted and donot disrupt the endothelium or have an intraluminal component makes themideal” for achieving the goals of kidney transplantation. V. E.Papalois, J. Romagnoli, and N. S. Hakim, Use of Vascular Closure Staplesin Vascular Access for Dialysis, Kidney and Pancreas Transplantation,International surgery, Vol. 83 (1998) p. 180. These goals include theavoidance of post-operative thrombosis and the avoidance of renal arterystenosis. As with kidney transplants, no anastomotic abnormalities weredetected in pancreatic transplants, where the avoidance of arterialstenosis is also very important. Id., p. 180. The results of anastomosesperformed for providing vascular access for dialysis were also reportedsuccessful. Id., p. 179. In addition, it has been reported that the “VCSapplier is easy to manipulate, is as safe as hand-suture methods, andhas time saving potential. VCS clips are useful for vascular anastomosesof blood access.” Hiroaki Haruguchi, Yoshihiko Nakagawa, Yasuko Uchida,Junichiro Sageshima, Shohei Fuchinoue and Tetsuzo Agishi, ClinicalApplication of Vascular Closure Staple Clips for Blood Access Surgery,ASAIO Journal, Vol. 44(5) (1998) pp. M562-M564.

In a study of microvascular anastomosis of rabbit carotid arteries, someanastomosis were stapled using non-penetrating 0.9 mm microclips andsome anastomosis were conventionally sutured Arcuate-legged,nonpenetrating titanium clips are applied according to a clippingtechnique in an interrupted fashion to everted tissue edges at highcompressive forces. It is considered that this technique “enables rapidand precise microvascular reconstructions, but requires both trainingand evertable tissue walls.” Nonpenetrating Clips for CoronaryAnastomosis, Annals of Thoracic Surgery, p. S135. An example of thisclip applier is the VCS device, Autosuture, United States SurgicalCorporation, Norwalk, Conn. Nonpenetrating Clips for CoronaryAnastomosis, pp. S135-S137. U.S. Pat. No. 5,702,412 discloses a methodand devices for performing end-to-side anastomoses where the side wallof one of the structures is cut from the intraluminal space of the graftvessel and the anastomosed structures can be secured by a plurality ofclips or by suturing.

It has been concluded that stapled microvascular anastomosis is fast andreliable and histomorphologic examination of the anastomotic siterevealed no major differences between sutured and stapled groups.Microscopic Analysis of Stapled Microvascular Anastomosis, p. S128.Furthermore, it has also been reported that the “clipped anastomotictechnique has a rapid learning curve, the same safety as suture methods,and the potential for facilitating endoscopic vascular reconstruction.”Nonpenetrating Clips for Coronary Anastomosis, p. S135. In a studyundertaken to compare VCS clips with sutured arterial end-to-endanastomosis in larger vessels, it was concluded that this type ofanastomosis “can be performed more rapidly with VCS clips thancontinuous sutures”, and that VCS clips “are potentially usefulsituations where the clamp time of the vessel is critical.” EmmanouilPikoulis, David Burris, Peter Rhee, Toshiya Nishibe, Ari Leppniemi,David Wherry and Norman Rich, Rapid Arterial Anastomosis with TitaniumClips, The American Journal of Surgery, Vol. 175 (1998) pp. 494-496.

Nevertheless, clipping may lead to irregularities at the junction of theanastomosed vessels. In addition, it has been reported that “bothperiadventitial tissue stripping and microvascular clip application havedeleterious effects in the early postoperative period” and that“temporary clips with a lesser width must be used in place ofmicrovascular clips” while performing microvascular anastomosis. S.Keskil, N. Ceviker, K. Baykaner,. Uluo{haeck over (g)}lu and Z. S.Ercan, Early Phase Alterations in Endothelium Dependent VasorelaxationResponses Due to Aneurysm Clip Application and Related Manipulations,Acta Neurochirurgica, Vol. 139(1) (1997) pp. 71-76.

2.2.2. Coupling

Tissue bonding by coupling with the aid of devices such as stents,ferrules, or rings without staples is considered to be older thanstapling. Among the more recent devices and techniques, U.S. Pat. No.4,523,592 discloses anastomotic coupling means capable of end-to-end andend-to-side anastomosis without resorting to suturing. The vessels arecoupled with a pair of coupling disc members that cooperatively lock andsecure the everted tissue from the anastomosed structures. These evertedtissues remain in intima-intima contact with no foreign material exposedto the lumen of the anastomosed vessels. U.S. Pat. Nos. 4,607,637,4,917,090 and 4,917,091 also disclose the use of anastomosis rings andan instrument for joining vessels or tubular organs which are threadedto the annular devices before the joining. The instrument and theanastomosis rings are shaped and adapted to be utilized mainly inmicrosurgery. U.S. Pat. Nos. 4,657,019 and 4,917,087 disclose devices,kits and methods for non-suture end-to-end and end-to-side anastomosisof tubular tissue members that employ tubular connection members andprovide intima-intima contact at the anastomosis site with no foreignmaterial exposed to the lumen of the vessels being joined. An annulipair that provides an anastomotic clamp and that is especially adaptedfor intraluminal disposition is disclosed in U.S. Pat. No. 5,336,233.Because of the intraluminal disposition, this device is exposed to theblood flow in the anastomosed vessels. U.S. Pat. No. 4,907,591 disclosesa surgical instrument for use in the installation of an assembly ofinterlocking coupling members to achieve compression anastomosis oftubular structures. Other coupling devices include the use ofintraluminal soluble stents and extraluminal glues, such ascyanoacrylates, for creating nonsuture anastomoses. Reportedly, 98%patency was obtained with these soluble polyvinyl alcohol stents. Reviewof Facilitated Approaches to Vascular Anastomosis, pp. S124-S125. Anabsorbable anastomotic device for microvascular surgery relies on thecuffing principle with injection-molding techniques using the polymerpolyglactin. Vessel ends that are everted 180.degree. are joined in thistechnique by an interconnecting collar so that an intima-intima seal isachieved. Reportedly, 96% patency was obtained with these absorbableinterconnecting collars. Review of Facilitated Approaches to VascularAnastomosis, p. S125.

The major advantage of a coupling microvascular anastomotic device hasbeen reported to be the reduction in the time needed for a venousanastomosis, which decreases the total ischemic time. Maisie L. Shindo,Peter D. Constantino, Vincent P. Nalbone, Dale H. Rice and Uttam K.Sinha, Use of a Mechanical Microvascular Anastomotic Device in Head andNeck Free Tissue Transfer, Archives of Otolaryngology—Head & NeckSurgery, Vol. 122(5) (1996) pp. 529-532. Although a number of couplingtechniques do not place any foreign body in the intraluminal space ofthe anastomosed vessels, it is considered that the use of a foreignrigid body such as a ring that encloses a dynamically dilating structureis a disadvantage of this type of technique. Furthermore, this type oftechnique is viewed as not being flexible enough for its application tosignificant vessel size discrepancies in end-to-side anastomosis, andthe devices are characterized as being of limited availability andneeded in sets of different sizes. Microscopic Analysis of StapledMicrovascular Anastomosis, p. S 128. In addition, most couplingtechniques require considerable eversion, incisions and mounting of thecoupling devices that are difficult or impossible to applyendoscopically.

2.2.3. Adhesives

Pasting by applying adhesives or glues is widely employed in medicine.Several glues have been tested in anastomotic procedures, includingfibrin glue, cyanoacrylic glues and photopolymerizable glues.

Fibrin glue is a biological two-component sealant comprising fibrinogensolution and thrombin combined with calcium chloride solution. Thesecomponents are typically available deep-frozen in preloaded syringes,and they are mixed during application after thawing. Commerciallyavailable fibrin glue Tissucol has reportedly been approved by the Foodand Drug Administration for use in the United States. See, ThomasMenovsky and Joost de Vries, Use of Fibrin Glue to Protect Tissue DuringCO₂₂ Laser Surgery, Laryngoscope Vol. 108 (1998) pp. 1390-1393. Thisarticle will hereinafter be referred to as “Fibrin Glue in LaserSurgery.”

The use of fibrin glue has been found to be practical in telescopinganastomoses and in microanastomoses. Satoru Saitoh and Yukio Nakatsuchi,Telescoping and Glue Technique in Vein Grafts for Arterial Defects,Plastic and Reconstructive Surgery, Vol. 96(6) (1995) pp. 1401-1408;Seung-Kyu Han, Sung-Wook Kim and Woo-Kyung Kim, MicrovascularAnastomosis With Minimal Suture and Fibrin Glue: Experimental andClinical Study, Microsurgery, Vol. 18(5) (1998) pp. 306-311. Incontrast, it has been reported that the application of thrombin-basedfibrin sealant (fibrin glue) to microvascular anastomoses can havenoticeable deleterious effects, particularly when used in venousanastomosis. Christopher A. Marek, Lester R. Amiss, Raymond F. Morgan,William D. Spotnitz and David B. Drake, Acute Thrombogenic Effects ofFibrin Sealant on Microvascular Anastomoses in a Rat Model, Annals ofPlastic Surgery, Vol. 41(4) (1998) pp. 415-419.

A biological procoagulant solution has been described as promising. Themixture contains bovine microfibrillar collagen and thrombin. GaryGershony, John M. Brock and Jerry S. Powell, Novel Vascular SealingDevice for Closure of Percutaneous Vascular Access Sites,Catheterization and Cardiovascular Diagnosis, Vol. 45(1) (1998) pp.82-88; Ted Feldman, Percutaneous vascular Closure: Plugs, Stitches, andGlue, Catheterization and Cardiovascular Diagnosis, Vol. 45(1) (1998) p.89; Zoltan G. Turi, Plugging the Artery With a Suspension: A CautiousAppraisal, Catheterization and Cardiovascular Diagnosis, Vol. 45(1)(1998) pp. 90-91.

Cyanoacrylic glues tested on vessels include methyl cyanoacrylate andbutyl cyanoacrylate, such as Histoacryl glue (butyl-2-cyanoacrylate).The ultra-violet polymerizable glue polyethyleneglycol 400 diacrylatehas also been tested and reported that it “is able to effectively sealvessel puncture sites and anastomotic junctions without acutelyaugmenting local vascular thrombogenicity.” G. A. Dumanian, W. Dascombe,C. Hong, K. Labadie, K. Garrett, A. S. Sawhney, C. P. Pathak, J. A.Hubbell and P. C. Johnson, A new Photopolymerizable Blood Vessel GlueThat Seals Human Vessel Anastomoses Without Augmenting Thrombogenicity,Plastic and Reconstructive Surgery, Vol. 95(5) (1995) pp. 901-907.

Glues used in anastomotic practice face the challenges inherent tofactors that include toxicity, thrombogenicity, vascular wall thinning,and mechanical strength of the joint. Review of Facilitated Approachesto Vascular Anastomosis, p. S125; Henk Giele, Histoacryl Glue as aHemostatic Agent in Microvascular Anastomoses, Plastic andReconstructive Surgery, Vol. 94(6) (1994) p. 897.

2.2.4. Lasers

Lasers have been used in angioplastic revascularization since about1984. See for example, Markolf H. Niemz, Laser Tissue Interactions, pp.216-221, Springer Verlag 1996, (this work will hereinafter be referredto as “Laser Tissue Interactions”); R. Viligiardi, V. Gallucci, R. Pini,R. Salimbeni and S. Gahberti, Excimer Laser Angioplasty in Human ArteryDisease, in Laser Systems in Photobiology and Photomedicine, edited byA. N. Chester, S. Martellucci and A. M. Scheggi, pp. 69-72, PlenumPress, New York, 1991; Timothy A. Sanborn, Laser Angioplasty, inVascular Medicine, edited by Joseph Loscalzo, Mark A. Creager and VictorBrounwald, pp. 771-787, Little Brown Co. Whereas balloon angioplastytypically fractures, compresses or displaces plaque material, laserangioplasty typically removes plaque material by vaporizing it. LawrenceI. Deckelbaum, Cardiovascular Applications of Laser Technology, in LaserSurgery and Medicine, edited by Carmen A. Puliafito, pp. 1-27,Wiley-Liss, 1996.

The refinement of anastomosis techniques that rely on laser has beenprogressing since the reportedly first use of a neodymiumyttrium-aluminum-garnet laser (“Nd-YAG laser”) on vascular anastomosisin 1979. Particularly in an end-to-side vascular anastomosis, the end ofa graft in the form of a tubular structure is connected to the side wallof a receiving vessel so that the anastomosed end of the graftencompasses the anastomosis fenestra, or artificial window, that hasbeen formed into the side wall of the receiving vessel. Consequently,lasers can be used in anastomoses for welding the anastomosed structuresand/or for opening the anastomosis fenestra. In addition to YAG lasers,such as Nd-YAG and Ho-YAG lasers, Excimer, diode, CO₂ and argon lasershave also been used in vascular anastomoses.

Laser welding has been defined as the process of using laser energy tojoin or bond tissues. Typically, laser welding relies on photothermaleffects, but efforts are being made to develop laser welding that relieson photochemical effects, where the laser radiation activatescross-liking agents that are expected to produce stronger links thanthose produced by photothermal welding. Lawrence S. Bass and Michael R.Treat, Laser Tissue Welding: A Comprehensive Review of Current andFuture Clinical Applications, in Laser Surgery and Medicine, edited byCarmen A. Puliafito, pp. 381-415. (This work will hereinafter bereferred to as “Laser Tissue Welding”).

Generally, the use of lasers in anastomotic practice faces thechallenges inherent to factors that include the cost of laser purchase,maintenance and training, radiation damage to surrounding tissue,aneurism formation, the need for about three or four sutures (versus thenine or ten sutures applied in conventional anastomosis), side effectsof heat-induced tissue welding, and mechanical failure at theanastomosis site. Review of Facilitated Approaches to VascularAnastomosis, pp. S125-S126; Laser Tissue Welding, pp. 407-410; Brian C.Cooley, Heat-induced Tissue Fusion For Microvascular Anastomosis,Microsurgery, Vol 17(4) (1996) pp. 198-208. It has been reported,however, that the “nonocclusive Excimer laser-assisted anastomosistechnique is safe and yields a high longterm patency rate inneurosurgical patients” and that there might be indications for thismethod in coronary bypass surgery. Cornelis A. F. Tulleken, Rudolf M.Verdaasdonk, and Hendricus J. Mansvelt Beck, Nonocclusive ExcimerLaser-Assisted End-to-Side Anastomosis, Annals of Thoracic Surgery, Vol.63 (1997) pp. S138-S142. (This article will hereinafter be referred toas “Nonocclusive Excimer Laser-Assisted End-to-Side Anastomosis”). Inaddition, laser anastomosis is considered to offer moderately reducedoperative time, reduced skill requirements, faster healing, ability togrow, and possibly reduced intimal hyperplasia. Laser Tissue Welding,pp. 407-410 (further reporting on selected microvascular anastomosisstudies with lasers that include CO₂, argon, and diode lasers).Furthermore, research is being done to replace some of the initial lasersources by other lasers that are believed to be more suitable forclinical applications. For example, recent work with the 980 nm diodelaser indicates that it may “replace in the near future laser sources ofolder conception such as the Nd-YAG.” W. Cecchetti, S. Guazzieri, A.Tasca and S. Martellucci, 980 nm High Power Diode Laser in SurgicalApplications, in Biomedical Optical Instrumentation and Laser-AssistedBiotechnology, edited by A. M. Verga Scheggi, S. Martellucci, A. N.Chester and R. Pratesi, pp. 227-230, Kluwer Academic Publishers,Dordrecht, The Netherlands, 1996.

The CO₂ laser can seal blood vessels, including small blood vessels ofabout 0.5 mm in diameter or less and it has been used in microvascularanastomosis such as in human lympho-venous anastomosis. D. C. Dumitrasand D. C. A. Dutu, Surgical Properties and Applications of Sealed-offCO₂ Lasers, in Biomedical Optical Instrumentation and Laser-AssistedBiotechnology, edited by A. M. Verga Scheggi, S. Martellucci, A. N.Chester and R. Pratesi, pp. 231-239, Kluwer Academic Publishers,Dordrecht, The Netherlands, 1996. In addition to the CO₂ laser which isan efficient vaporizer of tissue, other lasers that effectively vaporizetissue include the argon and the KTP/532 lasers. Lasers—Invention toApplication, p. 106.

The argon laser has been reported to offer advantages over conventionalend-to-end anastomosis procedures applied to growing vessels. EijiChikamatsu, Tsunehisa Sakurai, Naomichi Nishikimi, Takashi Yano and YujiNimura, Comparison of Laser Vascular Welding, Interrupted Sutures, andContinuous Sutures in Growing Vascular Anastomoses, Lasers in Surgeryand Medicine, Vol. 16(1) (1995) pp. 34-40. It has also been reportedthat low temperature argon laser welding limits anastomoticthrombogenicity, which is thought of as a factor that may improve earlypatency of venous and small arterial bypass grafts. Steven B. Self,Douglas A. Coe and James M. Seeger, Limited Thrombogenicity of LowTemperature Laser-Welded Vascular Anastomoses, Lasers in Surgery andMedicine, Vol. 18(3) (1996) pp. 241-247.

The use of laser for medical purposes requires safety measures forprotecting health care practitioners who handle the laser device and forshielding surrounding tissues and avoiding unintended radiation induceddamage. Laser shield materials include layers of polymethylmethacrylateand tinfoil. See, Christine C. Nelson, Krystyna A. Pasyk and Gregory L.Dootz, Eye Shield for Patients Undergoing Laser Treatment, AmericanJournal of Opthalmology Vol. 110 (1990) pp. 39-43. Laser shieldmaterials are known and they have been disclosed in a variety of sourcessuch as Alex Mallow and Leon Chabot, Laser Safety Handbook, Van NostrandReinhold Co., New York (1978), and A. Roy Henderson, A Guide to LaserSafety, Chapman & Hall, London (1997). In particular, for example, thebiological sealant fibrin glue can prevent severe damage to tissue whenaccidentally exposed to CO₂ laser radiation and intraoperative coatingwith fibrin glue can serve as a shield to protect arteries, veins, andnerves from accidental CO₂ laser exposure. Furthermore, it is consideredthat the use of fibrin glue for laser radiation protective processes “isespecially attractive in . . . fields in which the glue is already usedfor sealing.” Fibrin Glue in Laser Surgery at p. 1393.

2.2.5. Other Devices and Techniques

It is known that some anastomosis techniques combine differentapproaches. For example, biological glues that are based on proteins andother compounds are combined with laser radiation in laser soldering.“Laser soldering is a bonding technique in which a proteinaceous soldermaterial is applied to the surfaces to be joined followed by applicationof laser light to seal the solder to the tissue surfaces.” Laser TissueWelding, pp. 389-392. Egg albumin, heterologous fibrin glue, and humanalbumin have been used as laser solders, also known as adjuvantmaterials for laser tissue welding. Dix P. Poppas, Theodore J. Choma,Christopher T. Rooke, Scott D. Klioze and Steven M. Schlossberg,Preparation of Human Albumin Solder for Laser Tissue Welding, Lasers inSurgery and Medicine, Vol. 13(5) (1993) pp. 577-580.

In an even newer technique, a chromophore is added to the solder toachieve photoenhancement effects that lead to an enhanced lightabsorption in the solder and not in the nontargeted tissue. Id., p. 391.In laser sealing, also known as laser-activated tissue sealing, suturedor stapled repairs are reinforced with laser solder, which is expectedto provide “the strength and security of sutures and the watertightnessof solder.” Id., pp. 403-404.

The graft in a vascular anastomosis does not necessarily have to be anautologous blood vessel. In addition to ePTFE tubular grafts that havebeen referred to in a preceding subsection, several synthetic materialsfor vascular grafts have been used or are being developed.

Synthetic biomaterials that are being developed include polymericmaterials with the proteins elastin and fibronectin. A. Maureen Rouhi,Contemporary Biomaterials, Chemical & Engineering News, Vol. 77(3)(1999) pp. 51-63.

ePTFE has been used with a variety of coatings. One type of coatingincludes fibrin glue that contains fibroblast growth factor type 1 andheparin. John L. Gray, Steven S. Kang, Gregory C. Zenni, Dae Un Kin,Petre I. Kim, Wilson H. Burgess, William Drohan, Jeffrey A. Winkels,Christian C. Haudenschild and Howard P. Greisler, FGF-1 AffixationStimulates ePTFE Endothelialization without Intimal Hyperplasia, Journalof Surgical Research, Vol. 57(5) (1994) pp. 596-612; Joseph I. Zarge,Vicki Husak, Peter Huang and Howard P. Greisler, Fibrin Glue ContainingFibroblast Growth Factor Type 1 and Heparin Decreases PlateletDeposition, The American Journal of Surgery, Vol. 174(2) (1997) pp.188-192; Howard P. Greisler, Claire Gosseli, Dewei Ren, Steven S. Kangand Dae Un Kin, Biointeractive Polymers and Tissue Engineered BloodVessels, Biomaterials, Vol. 17(3) (1996) pp. 329-336. Another coatingcontains basic fibroblast growth factor in fibrin glue. M. Lanzetta, D.M. Crowe and M. J. Hickey, Fibroblast Growth Factor Pretreatment of 1-mmPTFE Grafts, Microsurgery, Vol. 17(11) (1996) pp. 606-611.

Other grafts comprise a synthetic biodegradable tubular scaffold, suchas a vessel made of polyglactin/polyglycolic acid, that has been coatedwith autologous cells from a tissue culture. Toshiharu Shinoka,Dominique Shum-Tim, Peter X. Ma, Ronn E. Tanel, Noritaka Isogai, RobertLanger, Joseph P. Vacanti and John E. Mayer, Jr., Creation of ViablePulmonary Artery Autografts Through Tissue Engineering, The Journal ofThoracic and Cardiovascular Surgery, Vol. 115(3) (1998) pp. 536-546.

A common feature of most conventional stapling, coupling and clippingtechniques, particularly when applied to small-diameter vessels, is thatthey require a temporary interruption of the blood stream in therecipient vessel, a disruption that is thought to be not very welltolerated in cardiac bypass surgery. Review of Facilitated Approaches toVascular Anastomosis, p. S126. In revascularization procedures of thebrain, temporary occlusion of a proximal brain artery may cause brainischemia, and consequently a nonocclusive anastomosis technique isrequired. Nonocclusive Excimer Laser-Assisted End-to-Side Anastomosis,p. 141. As the instrumentation that is needed at the anastomosis sitebecomes complex and cumbersome, a wider open area is needed foraccessing the anastomosis site, thus leading to an increasingly invasiveprocedure. Furthermore, conventional anastomosis techniques are usuallyperformed at a site that is determined by external observation of theaffected area. This observation is performed at a time and in a medicalsetup that are different from the time and medical setup of a previousexploratory or diagnosis procedure.

Techniques that require the perforation of blood vessel tissue haveraised concerns regarding intimal injury, adventitial stripping, tissueplane malalignment, and anastomotic bleeding. In addition, techniquesthat rely on devices that are exposed to the blood flow may lead totechnical problems associated with a persistent intraluminal foreignbody. These factors are thought to “contribute to both early and lateanastomotic failure, particularly in the form of neointimalhyperplasia.” Nonpenetrating Clips for Coronary Anastomosis, p. S135.

The need for completely endoscopic anastomosis procedures has beenclearly expressed in the context of coronary artery bypass grafting. Forexample, it is currently acknowledged that “the goal of a completelyendoscopic coronary artery bypass procedure has not yet been realized,and will require further technological advances.” Endoscopic CoronaryArtery Bypass Grafting, p. 1064. Furthermore, totally endoscopiccoronary artery bypass grafting “is perceived by many as the ultimatesurgical model of minimally invasive coronary artery bypass grafting”.Hani Shennib, Amr Bastawisy, Michael J. Mack, and Frederic H. Moll,Computer-Assisted Telemanipulation: An Enabling Technology forEndoscopic Coronary Artery Bypass, Annals of Thoracic Surgery, Vol. 66(1998) p. 1060.

Minimally invasive vascular grafting according to a peripheral procedureis equally desirable, and minimally invasive active endoscopic orperipheral methods, systems and devices are specially desirable. Inaddition, methods, systems and devices that can be used in catheterdirected as well as in non-catheter directed vascular anastomosis areparticularly desirable because sometimes an occluded or damaged vesseldoes not permit catheterization from a point that is too far from theanastomosis site.

These methods, systems and apparatuses are specially desirable when, inparticular, they are versatile enough as to be able to incorporate aplurality of the desirable features that have been discussed hereinabovewhile reviewing different groups of vascular anastomosis techniques.This desirability is consistent with the reported expectation thatreliable methods for facilitated anastomosing of vessels will bedeveloped by combining the best features of a variety of techniques.Review of Facilitated Approaches to Vascular Anastomosis, p. S126.

Each one of the afore-mentioned patents and publications is herebyincorporated by reference in its entirety for the material disclosedtherein.

OBJECTS AND BRIEF SUMMARY OF THE INVENTION

Conventional anastomosis techniques do not rely on intraluminallydirected anastomosis procedure. It is therefore desirable to providemethods, systems and devices for achieving intraluminally directedanastomosis.

An object of the present invention is to provide apparatus, methods,systems for performing an anastomosis through use of an intraluminallydirected anvil apparatus or alternatively an externally positioned anvilapparatus.

Another object of this invention is to provide systems and apparatusthat work in conjunction with an intraluminally directed anvil apparatusto anastomose vessels together.

Additionally, another object of this invention is to provide methods,systems, and devices for joining vessels together in a secure mannersuch that the portions defining the openings of the vessels are notpenetrated.

Additionally, another object of this invention is to provide methods,systems, and devices for joining vessels together through the use ofplates that are guided to each other by guides.

Still another object of the present invention is to provide methods,systems, and devices that are versatile enough to be able to suitablycombine a variety of cutting, welding, and joining techniques in thepractice of vascular anastomosis.

A feature of this invention is that the anvil apparatus can bepositioned in a vessel intraluminally such that an anvil abuts the wallof the vessel with an anvil pull extending through an initial piercingin the vessel wall. This is preferably achieved through the use of acatheter inserted into and along the intraluminal space of a receivingblood vessel. Because the initial piercing is too small for the anvil topass through, the anvil pull can be pulled in a manner that causes thewall of the vessel to be distended.

The opening is formed in a manner that consistently creates a completecut having a perimeter with a desired shape such as a circle or anellipse depending on the type of anastomosis. The precision of thecutting is due to several features. As mentioned above, the vessel wallis distended over the anvil which enables the wall to be stretched. Thisassists in creating a clean cut. The anvil is larger than the cutter sothat the cut is formed due to the pressure between anvil and the cutterinstead of forcing the vessel between the cutter and the anvil. Also,the anvil is preferably configured such that it has an engaging end thatis convex and is more preferably spherical so that when engaged by acylindrical cutter the cutter can self center on the engaging end. Thecutter is also preferably spring biased which provides increasedpressure for engaging the anvil.

The ability to distend the vessel wall is particularly useful when acompression plate apparatus is utilized to join the vessels. Thiscompression plate apparatus includes two opposing and generally annularcompression plates in a generally coaxial orientation. The end of thegraft vessel that is to be anastomosed is everted onto one of thecompression plates. The anvil pull is used to distend the receivingvessel wall such that it extends into compression plate apparatus. Withthe other compression plate placed at and around the anastomosis site,an anastomosis fenestra is opened in the wall of the receiving vessel.This anastomosis fenestra is opened within the annular region generallydefined by the compression plate located at and around the anastomosissite. With the aid of the anvil of this invention, the contour of theanastomosed fenestra is engaged with the compression plate which opposesthe compression plate that carries the graft vessel. This engagement ispreferably accomplished with the aid of holding tabs protruding from thecompression plate placed around the anastomosis fenestra. The degree towhich the anvil has distended the receiving vessel before formation ofthe fenestra determines the size of the portion defining the vesselopening that remains in the compression plate apparatus. By adequatelydistending the receiving vessel wall, the portion defining the openingcan be captured by the compression plate apparatus and everted. Thegraft vessel is subsequently approached to the anastomosis fenestra byreducing the separation between the compression plates, so that thegraft vessel causes the eversion of the contour of the anastomosisfenestra by appropriately sliding on the surface of the anvil. Once theportion of the vessel that defines the opening has been everted then thecompression plate apparatus can be compressed in a manner such that theeverted portion of the receiving vessel is held against the evertedportion of the other vessel such as a graft vessel. The relativeseparation of the compression plates is reduced to the extent necessaryto bring the everted edges of the anastomosed structures into contactengagement so that a leak proof anastomosis is achieved.

A feature of the present invention is that the compression plateapparatus is suitable for end-to-side anastomosis in addition toside-to-side anastomosis. Furthermore, the compression plate apparatusof this invention provides support to the anastomosed structures in amanner such that the compression plates do not disrupt the periodicdilation of the anastomosed structures as is required by thecharacteristics of the blood flow that circulates therethrough.Moreover, the compression plate apparatus of this invention is used,together with the anvil, to evert the contour of the anastomosedfenestra in the receiving vessel while the anastomosis takes place. Inaddition, the compression plate apparatus of this invention can be usedin conjunction with an anvil and anvil pull, regardless of whether thevascular anvil and wire are introduced into the receiving blood vesselwith the aid of a catheter or directly into the intraluminal spacethrough a small incision at the anastomosis site.

Another feature of the present invention is that the anvil is configuredin a way such that it cooperates with the cutting element in the openingof the anastomosis fenestra and it also cooperates with the compressionplate apparatus in the eversion of the edge of the anastomosed fenestra.By joining the everted contour of the anastomosis fenestra with theeverted edge of the graft vessel, significant exposure to the blood flowof the cut portion of the anastomosed structures is avoided.Furthermore, the use of the anvil in a plurality of operations permits aconsiderable simplification of the anastomosis procedure. Theseoperations include the abutting of the receiving blood vessel wall atthe anastomosis site, the opening of the anastomosis fenestra in thereceiving blood vessel, the eversion of edge of the anastomosisfenestra, and the joining of the anastomosed structures.

As discussed in more detail hereinbelow, the opening of the anastomosisfenestra can be performed mechanically or with the aid of aradiation-based device. The graft vessel is joined to the wall of thereceiving blood vessel by a compression plate device. This device isconfigured in a manner such that it permits the use of supplementingjoining techniques and combinations thereof. These techniques includewelding, soldering, and gluing. Moreover, the signaling of theanastomosis site is preferably performed with the aid of a mechanicaldevice such as the combination of a wire and an anvil.

The compression plate apparatus may be two opposing plates that areguided to each other as they are compressed together by guides whichensure that the plates maintain a parallel orientation with respect toeach other. The compression plate apparatus may also be a snap-fitapparatus which ensures that the vessels are held together withoutpenetrating the portions of the vessels that define the openings.

Many of the features obtained through the use of an intraluminallydirected anvil apparatus can also be utilized in conjunction with anexternally positioned anvil apparatus. For example, the advantageouscutting properties achieved with an intraluminally positioned anvilapparatus engaging a cutter as described above can also be used by ananvil apparatus that has been positioned within the lumen of a vessel byinserting the anvil through an insertion opening in the vessel.

An external anastomosis operator is also provided that controls theanastomosis procedure once the anvil pull extends out of the wall of thevessel and can be engaged. The external anastomosis operator enables theanastomosis procedure to mechanized so that it is rapidly and reliablycompleted in a highly controlled manner. The external anastomosisoperator can also be utilized with an anvil apparatus that has beenpositioned externally into a vessel as well as the compression plates.

One advantage of performing a minimally invasive anastomosis under theactive endoscopic or peripheral procedure that is based on the methods,systems, and devices of the present invention is that its practice doesnot require the training in surgical methods and techniques that thepractice of surgery requires. Cross-specialty teams of practitionersincluding those with training in endovascular intervention as well asconventional surgical training can consequently perform minimallyinvasive anastomoses according to the methods, apparatuses, and systemsof this invention.

Another feature of the active endoscopic or peripheral procedure of thisinvention is that it directly employs information while it is beingacquired in an angiographic examination. This efficient use ofinformation, and in particular imaging, has the advantage that theanastomosis is actually performed in less time and without having torely on the correlation of previously recorded images with externalanatomic inspection for locating the optimal anastomosis site. Theshorter procedure according to this invention consequently requires lessor no hospitalization time and less medical resources.

Still another feature of the active endoscopic or peripheral procedureof this invention is that it requires no sutures. The avoidance ofsutures has the advantages of reducing the invasive character of theprocedure, reducing the number of mechanical elements in the practice ofthe anastomosis, and shortening the time needed to perform theanastomosis.

By not requiring the interruption of blood flow in the receiving bloodvessel, the active endoscopic or peripheral procedure of this inventionadvantageously reduces or even eliminates the risk of ischemia in organsthat receive their main supply of blood through the receiving bloodvessel. Furthermore, the exposure of the anastomosis area is reducedbecause no devices have to be introduced to temporarily interrupt bloodflow. This feature advantageously enhances the minimally invasivecharacter of the methods, systems, and apparatuses of this invention andthe intervention time for the practice of the anastomosis.

The minimal disruption of blood flow in the receiving blood vessel bythe active endoscopic or peripheral procedure of this inventionadvantageously makes it suitable in the context of coronary arterybypass grafting (CABG), whether blood circulation is intracorporeal orextracorporeal, and whether the grafting is performed on a beating heartor an arrested heart.

A feature of the catheter assisted endoscopic or peripheral procedure ofthis invention is the versatility of the vascular anvil and wire forsignaling the anastomosis site and of the extravascular device andcooperatively performing the anastomosis. Accordingly, a variety ofdevices and techniques can be advantageously combined in the context ofthis invention to enhance the performance of its methods, systems anddevices.

These and other objects, features, and advantages of the presentinvention will become more fully apparent from the following descriptionand appended claims, or may be learned by the practice of the inventionas set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the above-recited and other advantagesand objects of the invention are obtained, a more particular descriptionof the invention briefly described above will be rendered by referenceto specific embodiments thereof which are illustrated in the appendeddrawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered tobe limiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 is a perspective view of a patient receiving a catheter at acatheterization site as a guide wire is directed to a remote anastomosissite.

FIG. 2A is an enlarged partial cross-sectional view of a vessel with thecoil of a guide wire positioned at the selected anastomosis site.

FIG. 2B is an enlarged partial cross-sectional view of the vessel shownin FIG. 2A depicting the next phase of utilizing the catheter systemafter a positioning catheter is positioned at the anastomosis site.

FIG. 2C is an enlarged partial cross-sectional view of the vessel shownin FIG. 2B depicting the next phase of utilizing the catheter system asthe penetration catheter and the penetration wire extending through aninitial piercing at the anastomosis site.

FIG. 2D is an enlarged partial cross-sectional view of the vessel shownin FIG. 2C depicting the next phase of utilizing the catheter systemafter the penetration wire has been removed so that only the penetrationcatheter remains.

FIG. 2E is an enlarged partial cross-sectional view of the vessel shownin FIG. 2D depicting the next phase of utilizing the catheter system asan anvil pull of an intraluminally directed anvil apparatus is insertedthrough the penetration catheter.

FIG. 2F is an enlarged partial cross-sectional view of the vessel shownin FIG. 2E after the anvil pull of an intraluminally directed anvilapparatus has been pulled through the wall of the vessel 20 so that theanvil is brought into contact with the interior of the vessel.

FIG. 3A is a perspective view of a guided compression plate apparatuswith phantom lines to show the compressed position.

FIG. 3B is a perspective view of the guided compression plate apparatusshown in FIG. 3A with a graft vessel loaded onto the holding tabs of thesecond compression plate and a cutter positioned to be loaded into thelumen of the graft vessel.

FIG. 4A is a cross-sectional view of the compression plate apparatusshown in FIG. 3A as anvil apparatus distends a blood vessel into thecompression plate apparatus.

FIG. 4B is a cross-sectional view of the compression plate apparatusshown in FIG. 4A in the next phase as a cutter and an anvil are engagedto form an opening in the vessel.

FIG. 4C is a cross-sectional view of the compression plate apparatusshown in FIG. 4B in the next phase after the second compression platehas been compressed towards the first compression plate such that theeverted graft vessel contacts the everted blood vessel.

FIG. 4D is a cross-sectional view of the compression plate apparatusshown in FIG. 4C with the anastomosed structure after the anvilapparatus and the cutter have been removed.

FIG. 5A is a perspective view of the guided compression plate apparatusshown in FIG. 3A with a graft vessel loaded onto the holding tabs of thesecond compression plate, a cutter positioned in the lumen of the graftvessel and an adapter ready to be positioned on the second compressionplate.

FIG. 5B is a perspective view of the guided compression plate apparatusshown in FIG. 3A with a graft vessel loaded onto the holding tabs of thesecond compression plate, a cutter positioned in the lumen of the graftvessel and an adapter positioned on the second compression plate.

FIG. 6A is a perspective view of an external anastomosis operator.

FIG. 6B is an exploded perspective view of the external anastomosisoperator.

FIG. 6C is a cross-sectional view of the external anastomosis operator.

FIG. 6D is a cross-sectional view of the external anastomosis operatoras the anvil pull advancer knob is rotated to pull the anvil pull sothat the anvil causes distension of the blood vessel into thecompression plate apparatus.

FIG. 6E is a cross-sectional view of the external anastomosis operatoras the attachment actuator device is moved to compress the secondcompression plate against the first compression plate.

FIG. 7A is a perspective view of an alternative embodiment of an anvilhaving a slightly tapered landing.

FIG. 7B is a perspective view of an alternative embodiment of an anvilhaving a flared flange.

FIG. 7C is a perspective view of an alternative embodiment of an anvilhaving a tapered terminal end.

FIG. 7D is a perspective view of an alternative embodiment of an anvilhaving an elliptical engaging end and an eccentrically connected anvilpull.

FIG. 8 is an enlarged partial cross-sectional view of the vessel shownin FIGS. 2A-2F depicting an anvil pull of an intraluminally directedanvil apparatus pulled through the wall of the vessel 20 so that theanvil is brought into contact with the interior of the vessel after theapparatus has been positioned by a positioning stem extending from theanvil.

FIG. 9A is a perspective view of a mechanically expandable anvil.

FIG. 9B is a cross-sectional view of the anvil shown in FIG. 9A.

FIG. 10A is a perspective view of another mechanically expandable anvil.

FIG. 10B is a cross-sectional view of the anvil shown in FIG. 10A.

FIG. 11A is a perspective view of a chemically expandable anvil.

FIG. 11B is a cross-sectional view of the anvil shown in FIG. 11A.

FIG. 12A is a perspective view of a snap-fit compression plateapparatus.

FIG. 12B is a perspective view of the snap-fit compression plateapparatus shown in FIG. 12A with a graft vessel loaded onto the holdingsurface of the second compression plate.

FIG. 12C is a cross-sectional view of the compression plate apparatusshown in FIG. 12B as anvil apparatus distends a blood vessel into thecompression plate apparatus.

FIG. 12D is a cross-sectional view of the compression plate apparatusshown in FIG. 12A in the next phase as a cutter and an anvil are engagedto form an opening in the vessel.

FIG. 12E is an enlarged partial cross-sectional view of the compressionplate apparatus shown in FIG. 12D in the next phase as the graft vesseleverts the portion of the blood vessel defining the first vesselopening.

FIG. 12F is a cross-sectional view of the compression plate apparatusshown in FIG. 12B in the next phase after the second compression platehas been compressed towards the first compression plate such that theeverted graft vessel contacts the everted blood vessel.

FIG. 12G is a cross-sectional view of the compression plate apparatusshown in FIG. 12C with the anastomosed structure after the anvilapparatus and the cutter have been removed.

FIG. 13 is a perspective view of guided compression plate apparatusadapted for use in joining vessels at angles with elliptical openingswith a graft vessel ready to be received through a cutter and loadedonto the holding tabs of the second compression plate.

FIG. 14A is a perspective view of a cutter ready to engage an anvil witha thread anvil pull extending through the cutter to an anvil pullengager to form a circular opening.

FIG. 14B is a perspective view of a cutter ready to engage an anvil witha thread anvil pull extending through the cutter to an anvil pullengager to form an elliptical opening.

FIG. 14C is a perspective view of a clipping device applying clips tojoin two vessels in a nonperpendicular orientation.

FIG. 14D is a cross-sectional view of the device capable cutting,delivering radiation for soldering, delivering adhesives and otherfluids.

FIG. 15A is a perspective and partial cross-sectional view of thecompression plate apparatus shown in FIG. 3A being used in aside-to-side anastomosis while the first compression plate is held.

FIG. 15B is a cross-sectional view of the compression plate apparatusshown in FIG. 15A in the next phase as a cutter and an anvil are engagedto form an opening in the vessel.

FIG. 15C is a cross-sectional view of the compression plate apparatusshown in FIG. 15B in the next phase after the second compression platehas been compressed towards the first compression plate by an attachmentactuation device such that the everted graft vessel contacts the evertedblood vessel.

FIG. 16A is a perspective view of the anvil from FIG. 7C being insertedfrom the exterior of a blood vessel into the blood vessel lumen.

FIG. 16B is a perspective view of the blood vessel shown in FIG. 16Awith the anvil depicted in phantom lines and a stay suture around theinsertion opening.

FIG. 16C is a perspective view of the external anastomosis operatorcooperating with the anvil depicted in phantom lines to form ananastomosis.

FIG. 16D is a cross-sectional view of the compression plate apparatusshown in FIG. 3A as the anvil apparatus distends a blood vessel having astay suture around the insertion opening.

FIG. 16E is a cross-sectional view of the compression plate apparatusshown in FIG. 3A as the anvil apparatus distends a blood vessel afterbeing inserted into the lumen of the blood vessel through an insertionopening.

FIG. 17A is a perspective view of an externally positioned anastomosisfenestra cutting apparatus inserting an anvil through an insertionopening into the lumen of a blood vessel.

FIG. 17B is a perspective view of an externally positioned anastomosisfenestra cutting apparatus distending the vessel and being readied tocooperate with an anvil.

FIG. 17C is a cross-sectional view and the anvil pull of the externallypositioned anastomosis fenestra cutting apparatus shown in FIGS. 17A-17Bpulling the anvil so that the engaging end of the anvil engages thecutter and forms an opening.

FIG. 18A is a perspective view of an externally positioned anastomosisfenestra cutting apparatus cooperating with an elliptical anvil.

FIG. 18B is a cross-sectional view and the anvil pull of the externallypositioned anastomosis fenestra cutting apparatus shown in FIG. 18Apulling the anvil so that the engaging end of the anvil engages thecutter and forms an elliptical opening.

FIG. 19A is a cross-sectional view of a spring biased externallypositioned anastomosis fenestra cutting apparatus after the anvil hasbeen inserted through an insertion opening.

FIG. 19B is a cross-sectional view of the spring biased externallypositioned anastomosis fenestra cutting apparatus shown in FIG. 19A asthe anvil pull is pulled against the cutter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention focuses on vascular anastomosis methods, systems,and devices as well as related technology for forming the openings thatare subsequently anastomosed together. Numerous designs are disclosedherein for achieving the desired anastomosis. The following discussionfocuses mainly on the use of an intraluminally directed anvil apparatusand an external anastomosis operator that work together with variousanastomosis plate apparatus to join vessels together. However, somefeatures of the intraluminally directed anvil apparatus can also beutilized with externally positioned anvil apparatuses that are insertedinto a lumen through the wall of the lumen and are then utilized. Suchexternally positioned anvil apparatuses are also described.

Some of the main components that are utilized in accordance with thepreferred methodology for intraluminally directed anastomosis proceduresinclude a catheter system 100 and an intraluminally directed anvilapparatus 200. The catheter system 100 is used to remotely position theintraluminally directed anvil apparatus 200 from a catheterization siteto an anastomosis site. At the anastomosis site, additional maincomponents are utilized with the intraluminally directed anvil apparatus200 including a compression plate apparatus 300 and an externalanastomosis operator 700. The methodology for using these components isinitially described in the context of joining an end of an attachingvessel to a side of a receiving vessel, however, the same methodologycan be used with other anastomosis procedures such as side-to-sideanastomosis as also described below.

This methodology is described in the subsection below that is entitledMethodology Overview. The main components are described in detail in theMethodology Overview including the catheter system 100, theintraluminally directed anvil apparatus 200, the compression plateapparatus 300 and the external anastomosis operator 700. Thesecomponents are also described and contrasted with other embodiments ofthese components in sections entitled Anvils, Compression plateapparatus, External Anastomosis Operators.

Additional methodologies for utilizing these components and alternativeembodiments of these components are described in sections entitledSide-to-Side Anastomosis, Externally Directed Anastomosis, andExternally Positioned Anastomosis Fenestra Cutting Apparatus.

Methodology Overview

To optimally position intraluminally directed anvil apparatus 100,catheter system 100 is utilized as shown in FIG. 1 and FIGS. 2A-2F. FIG.1 depicts a patient undergoing the initial step of a procedure utilizedto remotely position the intraluminally directed anvil apparatus 200 atan anastomosis site 10 in a blood vessel 20 (not shown in FIG. 1) in thechest or arm such as the brachial artery from a catheterization site 40in a blood vessel in the patient's leg, the femoral artery. Cathetersystem 100 is shown in FIG. 1 with an introducer 110 inserted atcatheterization site 40 in the femoral artery. Introducer 110 permits aguide wire 120 to be inserted to the anastomosis site. Guide wire 120preferably utilizes a coil 125 to minimize the potential of the guidewire 120 to cause damage. Guide wire 120 typically follows afluoroscopic device, an endoscopic device or some other remote viewinginstrumentation or imaging technique used to determine the location forthe anastomosis site 10 such as the proximity of a blood vesselocclusion or another abnormality that has been detected by aconventional exploration technique. Any conventional guide wire suitedfor inserting both diagnostic and therapeutic catheters may be utilizedsuch as those disclosed in U.S. Pat. No. 4,846,186, which is herebyincorporated by reference in its entirety, and catheters and guide wiresfor vascular and interventional radiology are disclosed in Catheters,Methods, and Injectors, at 155-174, which is also hereby incorporated byreference in its entirety.

Hub 115 is shows at the proximal end of guide wire 120 in FIG. 1. Theproximal end of a catheter system such as catheter system 100 comprisesone or a plurality of access ports or luer fittings such as hub 115. Forthe purpose of simplicity, the proximal end of the various cathetersdepicted in FIGS. 2A-2E are not shown. However, the manufacture andhandling of a catheter system with a plurality of lumens and a pluralityof access ports are known to those of ordinary skill in the art. Forexample, U.S. Pat. Nos. 5,662,580 and 5,616,114, which have herein beenincorporated by reference in their entirety, disclose catheters with aplurality of access ports or luer fittings and a plurality of lumens.

FIG. 2A is an enlarged partial cross-sectional view of vessel 20 withcoil 125 of guide wire 120 positioned at the selected anastomosis site10. Once guide wire 120 has been positioned at anastomosis site 10, thena positioning catheter 140 and a straightening catheter 130 are pushedalong guide wire 120 until they reach the anastomosis site 10.Straightening catheter 130 has a tapered proximal end 135 that isadapted to minimize the impact of the positioning catheter 140 as theyare advanced within a blood vessel. Once the straightening catheter 130and positioning catheter 140 reach the anastomosis site 10, then guidewire 120 can be removed as shown by the phantom lines in FIG. 2A. Guidewire 120 is removed by pulling its distal end (not shown) that extendsout of catheterization site 40 until guide wire coil 125 exits thecatheterization site.

FIG. 2B depicts the next phase of utilizing catheter system 100.Positioning catheter 140 is designed to have an inherent curvature orcurved memory at its distal end. In order to enable positioning catheter140 to be moved as needed while moving through the patient's body to theanastomosis site, straightening catheter 130 extends within positioningcatheter 130 in order to straighten positioning catheter 140. Guide wire120 also assists in providing resistance to the inclination of thedistal end of the positioning catheter 130 to curve. Once anastomosissite 10 has been reached and the guide wire 120 has been removed, thencatheter system 100 appears as shown in FIG. 2A. The straighteningcatheter 130 is then withdrawn as shown in FIG. 2B, to permit the distalend of the positioning catheter 140 to curve against the wall of bloodvessel. An arrow is shown in FIG. 2B to indicate that a penetrationcatheter 150 containing a penetration wire 160 is inserted intostraightening catheter 140. The straightening catheter can be removed atthis point as indicated by the arrow in FIG. 2 b or it can remain.

FIG. 2C depicts penetration catheter 150 and penetration wire 160extending through an initial piercing 15 at anastomosis site 10 throughthe wall of blood vessel 20. Penetration wire 160 has a distal end 165that is sharp and pointed to enable it to pierce through the bloodvessel wall. Once the pointed distal end 165 of penetration wire 160 haspierced through the blood vessel wall then penetration catheter 150 canalso be pushed or pulled through the blood vessel wall.

FIG. 2D depicts catheter system 100 once positioning catheter 130 andstraightening catheter 140 have been removed from around penetrationcatheter 150 and once penetration wire 160 has been removed from withinpenetration catheter 160. At this point, penetration catheter 150extends from catheterization site 40 (not shown in FIG. 2D) toanastomosis site 10 through the wall of blood vessel 20 at initialpiercing 15. Catheter system 100, more particularly, penetrationcatheter 150 of catheter system 100 can then be used in association withthe intraluminally directed anvil anastomosis apparatus 200.

FIG. 2E shows penetration catheter 150 with its proximal end in apartial broken view to indicate that the anvil pull 230 of theintraluminally directed anvil apparatus 200 has been inserted intopenetration catheter 150 such that anvil pull 230 extends throughpenetration catheter 150 from the proximal end of penetration catheter150 at the catheterization site 40. Intraluminally directed anvilapparatus 200, referred to in abbreviated form as an anvil apparatus,includes an anvil 210 having an engaging end 212 from which the anvilpull 230 extends. Once the distal end 232, referred to herein as apenetration end of anvil pull 230, extends beyond the distal end ofpenetration catheter 150, then penetration end 232 alone or incombination with the distal end of penetration catheter 150 can begrasped so that the engaging end 212 of anvil 210 is brought intocontact with the interior, specifically the intima, of the vessel.

As shown in FIG. 2F, once the engaging end 212 of anvil 210 is broughtinto contact with the interior 22 of the wall of vessel 20 thenpenetration catheter 150 is removed. At this point, all components ofcatheter system 100 have been removed and only anvil 210 of anvilapparatus 200 remains in the lumen 28 of vessel 20.

The length of anvil pull 230 and the length of the various elements ofcatheter system 100 are suitably chosen depending on the distance fromthe catheterization site to the anastomosis site. For example, thislength would be approximately 180 cm long, depending on the patient'sheight, if an anastomosis were to be performed in a blood vessel in thearm such as the brachial artery, and catheter apparatus 100 wereinserted into the femoral artery.

In another embodiment of an anvil apparatus 200′ described below inreference to FIG. 9, the anvil apparatus may be positioned through theuse of a catheter system that comprises only a single catheter such aspositioning catheter 140. Since anvil apparatus 200′ is positioned at ananastomosis site by passing through a catheter such as positioningcatheter 140, it is necessary for the catheter to have dimensions thataccommodate the diameter or width of the anvil to be inserted. In someof the experiments performed in the context of this invention, acatheter characterized as a 13 French sheath, also known as a 4.3 mmcatheter—1 French unit=⅓ mm—, has been found suitable for most anvilapparatus insertions. Catheterization techniques are described, forexample, by Constantin Cope and Stanley Baum, Catheters, Methods, andInjectors for Superselective Catheterization, in Abrams' Angiography,edited by Stanley Baum, 4th ed., (this work will hereinafter be referredto as “Catheters, Methods, and Injectors”) which is hereby incorporatedby reference in its entirety. However, as described above, it ispreferable to utilize an anvil apparatus such as anvil apparatus 200 andto position the anvil against the wall of the blood vessel by pullingthe anvil pull 230 after it has been inserted into a penetrationcatheter 160. Penetration catheter need only be a 5 French sheath toreceive the anvil pull 230 of most anvil apparatus.

FIG. 2F shows that once anvil apparatus 200 has been positioned atanastomosis site 10 such that anvil pull 230 extends out of blood vessel20 through initial piercing 15 in the wall of the first vessel thenanvil pull 230 can be maneuvered to hold engaging end 212 of anvil 210against interior 22 of the wall of blood vessel 22. Note that sinceinitial piercing 15 is so much smaller than engaging end 212 of anvil210, anvil 210 cannot pass through initial piercing 15. This differencein size enables anvil 210 to be pulled against interior 22 in a mannersuch that the wall of vessel 20 can be distended. As discussed below,the ability to pull anvil pull 230 such that engaging end 212 of anvil210 engages interior 22 and distends the wall of vessel 20 contributessignificantly to the ability to evert the portions of the vessel wallaround an opening or anastomosis fenestra used for attaching anothervessel. Anvil 210 also has a cylindrical landing 214 which are itssidewall surfaces that assist in the eversion process as described belowin reference to FIGS. 4A-4D.

Anvil 210 and anvil pull 230 are preferably fixedly attached together.As shown, anvil pull 230 extends through anvil 210 via an anvil aperture216 (not shown) and terminates at a stopping element 236. Since theanvil pull is typically metal and the anvil is typically molded plastic,stopping element 236 may be just the proximal end of anvil pull 230embedded in anvil 210 such that it is still visible. Of course, theproximal end may be embedded in a way such that it is not visible asshown in FIG. 9B. In the embodiment shown in FIG. 2F, the stoppingelement 236 is the proximal end of anvil pull 230 that has been bent sothat it is partially embedded in terminal end 218 of anvil 210. Asdescribed below, anvil 210 and anvil pull 230 may also be integral.Additionally, anvil 210 may be movably positioned on anvil pull 230 inwhich case, stopping element 23 can be used to brace against terminalend 218 of anvil 210.

After the anvil 210 been positioned such that its engaging end 212contacts the intima of vessel 20 with anvil pull 210 extending throughthe wall of vessel 20, then anvil apparatus is ready to be utilized inan anastomosis procedure for joining vessel 20 with another vessel suchas graft vessel 50 which may be any synthetic graft vessel such as ePTFEtubular grafts. Numerous approaches are disclosed herein for joining aportion of a first vessel that define a first vessel opening to aportion of a second vessel that defines a second vessel opening suchthat the first vessel and the second vessel are anastomosed together andare in fluid communication. A preferred approach involves the use ofcompression plates that provide for a desired degree of eversion of thevessels without requiring penetration of the vessels. An example of suchcompression plates is the guided compression plate apparatus shown inFIG. 3A. Guided compression plate apparatus 300 is described in greaterdetail under the section titled Compression plate apparatus.

As can be seen from FIG. 3B, a graft vessel 50 is loaded onto holdingtabs 314 b of compression plate 314 while a cutter 400 is positioned tobe loaded into the lumen 58 of graft vessel 50. Cutter 400 includes acutting tube 410 that terminates at a cutting knife 412 with a cuttingedge 414. Note that a variety of cutters are disclosed herein asdiscussed in the section entitled Cutting Devices. Once cutter 400 ispositioned within graft vessel 50 as shown in FIG. 3C, then thecombination of compression plate apparatus 300, graft vessel 50 andcutter 400 are ready for use with anvil apparatus 200 to form ananastomosis. This combination is referred to herein as compression plateand cutter assembly 390 and is used much like a cartridge in theexternal anastomosis operator 700.

FIGS. 4A-4D depict the use of a compression plate apparatus 300 incombination with a cutter 400 and anvil 210 in the sequential orderaccording to the preferred methodology. To optimally present thissequence, FIGS. 4A-4D are cross-sectional views. FIG. 4A depicts anvil210 being pulled against the intima or interior of the vessel wall suchthat vessel 20 is sufficiently distended to permit the vessel 20 atanastomosis site 10 to be pulled into compression plate apparatus 300through first compression plate opening 320 a. More particularly, anvil210 is pulled by anvil pull 230 such that all of spherical engaging end212 is pulled into the compression plate apparatus 300 and most ofcylindrical landing 214. Cutter 400 also is shown in FIG. 4A extendingthrough second compression plate opening 320 b about half way throughcompression plate apparatus 300 as cutter 400 is approximated with theportion of the blood vessel 20 distended by anvil 210.

FIG. 4B depicts the formation of a first vessel opening 24 in the wallof the first vessel. First vessel opening 24 is formed by pulling anvilpull 230 through cutter 400 sufficiently to enable anvil 210 to advanceblood vessel 20 against cutting edge 414. After the cut has been madethen a cut portion 25 of the wall of blood vessel 20 remains onspherical engaging end 212 of anvil 210 while the portion 26 of theblood vessel that now define first vessel opening 24 rest on anvillanding 214. As will be discussed in the Cutting Devices section and theExternal Anastomosis Operator section, cutter 400 is preferably springbiased.

FIG. 4C depicts compression plate apparatus 300 after compression. Moreparticularly, compression plate 310 b has been moved toward compressionplate 310 a by sliding on guides 330 that extend from compression plate310 a. Note that the everted portion 56 of graft vessel 50, moreparticularly the portion 57 opposite from the rounded tip 316 b, isurged against portion 26 that defines first blood vessel opening 24 in amanner such that portion 26 has been everted. The end result is that theportion 27 opposite from rounded tip 316 a is held in contact with theportion 57 of vessel 50 opposite from distal rounded tip 316 b.

As shown in FIG. 4D, after compression plate apparatus 300 has beencompressed to join portion 26 of blood vessel 20 that defines firstvessel opening 24 to portion 56 of second vessel 50 that defines graftvessel opening 54 then first vessel 20 and second vessel 50 areanastomosed together and are in fluid communication. Anvil apparatus 200and cutter 400 have been removed upon the completion of the procedurethrough lumen 58 of graft vessel 50. More particularly, once theanastomosis is completed then anvil pull 230 is pulled so that it drawsanvil 210 through openings 320 a and 320 b of compression plateapparatus 300 such that anvil apparatus 200 is removed along with cutter400 through lumen 58. Note that terminal ends 332 of guides 330 havebeen removed since they are no longer necessary.

Compression plate 310 b does not slide on guides 330 after beingcompressed due to a frictional engagement. Several methods for achievingthis frictional engagement are s described below in the CompressionPlate Apparatus section below. Compression plate apparatus 300 utilizesa simplistic and yet effective frictional engagement as the guideapertures 334 in guide plate 310 b are sized such that significant forceis required to move plate 310 b on guides 330.

There are significant advantages to combining vessels in accordance withthe methodology described above especially in a manner such that thereis at least partial eversion, contact between the everted surfaces andno penetration of the portions of the vessels defining the vesselopenings. Of course, the anastomosis is fluid tight to normal systolicpressure and remains intact under stress. Since the everted portions 26and 56 respectively cover the holding tabs 314 a-b, no intraluminalforeign material is exposed and no subintimal connective tissue isintraluminally exposed. As a result, the thrombogenicity of theanastomoses is no greater than that of hand sutured anastomosis.Additionally, the configuration also results in an anastomosis that ismorphologically satisfactory, including complete eversion of thereceiving blood vessel intima with apposition to graft vessel. Further,everted portions 26 and 56′ are in intima-intima contact and no cutportion is significantly exposed to the blood flow that is to circulatethrough the anastomosed structures.

In addition to the results achieved, there are also significantprocedural advantages. The method does not require temporary occlusionof blood flow to the target blood vessel. The anastomosis can bereliably created. Additionally, the anastomosis is rapidly achieved andeliminates the need for high skilled suturing. For example, once theanvil pull extends through the wall of the vessel, the anastomosisprocedure can be accomplished in as little as 60 seconds whencompression plates are used to join the vessels.

Manual manipulation may be utilized to achieve the steps shown in FIGS.4A-4D, however, mechanization is preferred. More particularly, anvilpull 230 may be manually pulled as cutter 400 is held or manuallyadvanced. Additionally, compression plate apparatus may be manuallycompressed in some embodiments. Accordingly, components are not depictedin FIGS. 4A-4D for achieving these steps. However, as discussed indetail in the Compression Plate Apparatus section, Cutting Devicessections, and in the External Anastomosis Operator section, these stepsare preferably achieved through the use of devices specifically adaptedfor these purposes.

FIGS. 5A-5B depict the use of an optional second compression plateadaptor 610 b in combination with compression plate and cutter assembly390 as shown in FIG. 3B in preparation for use with the externalanastomosis operator shown in FIGS. 6A-6E at 700. The purpose ofoptional second compression plate adaptor 610 b is described below inrelation to the attachment actuation device 600. Note that there is across-sectional view of compression plate and cutter assembly 390 andoptional adaptor 610 b in FIG. 6C.

FIG. 6A provides a perspective view of external anastomosis operator 700with its main components identified including: cutter 400, springbiasing device 450, an anvil pull engager 500 which includes an anvilpull holder 530 and an anvil pull advancer 560, and an attachmentactuation device 600. Spring biasing device 450 is used to applypressure against the distal end 418 of cutter 400. The advantages ofusing a spring biased cutter are explained below in the Cutting Devicessection. Anvil pull 230 is fed through cutter 400, through springbiasing device 450 and into an anvil pull holder 530. An anvil pullholder 530 is preferably a clamp assembly adapted to hold anvil pull 230extending from anvil 210 such that holder 530 is locked into position onanvil pull 230. Anvil pull advancer 560 is adapted to pull anvil pull230 once anvil pull 230 is held by holder 530. As anvil pull advancer560 pulls on anvil pull 230, it causes anvil pull 230 to advance withincompression plate assembly 300 and distend the wall of vessel 20 untilcutter 400 is engaged. Anvil pull holder 530 and anvil pull advancer 560are described in greater detail below in the External AnastomosisOperator section in reference to FIGS. 6A-6E.

As shown in FIG. 6C, the assembly depicted in FIG. 5B is inserted suchthat the first compression plate 310 a is held via adaptor 610 a and thesecond compression plate 310 b is held via adaptor 610 b while distalend 418 of cutter 400 abuts spring biasing device 450. Anvil pull 230 isshown in FIG. 6C extending through cutter 400. Cutter 400 is hollow soit has a chamber 420 between the sidewalls of cutting tube 410. Cutter400 may also have an optional centering core 422 that extends at leastpart way though chamber 420. Centering core 422 has a centering conduit424 that assists in centering anvil pull 230 in cutter 400 such thatanvil pull 230 is essentially parallel with the sidewalls of cuttingtube. As discussed below in greater detail, it is not always necessaryfor cutter 400 to have a centering core or for other cutters to have acentering core or a centering conduit. When the engaging end of theanvil is spherical and the cutter is spherical and is configured suchthat it permits part of the spherical engaging end of the anvil to bepositioned in cutter chamber then the cutter self centers on thespherical engaging end.

As shown in FIG. 6D, anvil pull 230 is inserted through cutter 400,through spring biasing device 450 and into an anvil pull holder 530.Holder knob 540 of anvil pull holder 530 is then rotated as describedbelow to hold anvil pull 230. Once anvil pull holder 230 securely holdsanvil pull, then advancer knob 570 is rotated as shown in FIG. 6D.Rotation of advancer knob 570 causes anvil pull holder 530 to pull onanvil pull 230, which causes anvil pull 230 to advance withincompression plate assembly 300 and distend the wall of vessel 20 untilcutter 400 is engaged as depicted. Note that FIG. 4B depicts anvil 210engaging cutter 400 at the same point in the process as is shown in FIG.6D except FIG. 4B does not show any of the components of externalanastomosis operator being used.

FIG. 6E depicts attachment actuation device 600 being engaged. Asexplained above in reference to FIGS. 4A-4D, once the anastomosisfenestra or vessel opening 24 has been made then compression plateassembly 300 can be compressed such that first and second compressionplates 310 a-b are brought together. As indicated above, compressionplates 310 a-b are preferably approximated through the use ofappropriate devices. Attachment actuation device 600 achieves thispurpose. Attachment actuation device 600 is also described in detailbelow in the External Anastomosis Operator section in reference to FIGS.6A-6E. However, to appreciate the advantages of the preferredmethodology it should be understood that attachment actuation device 600is used to bring the compression plates together in the manner depictedin FIGS. 4A-4D. Attachment actuation device 600 has a first plateengager 600 a and a second plate engager 600 b. These plate holders 600a-b may directly hold first and second compression plates 310 a-b oroptional adapters 610 a-b may be utilized. FIGS. 12C-12F depict anotherembodiment of an attachment actuation device 600′ configured to holdcompression plates without adapters. Note that compression plateapparatus 300′ depicted in FIGS. 12C-12F is another embodiment of acompression plate apparatus with plates that snap-fit together. Firstplate engager 600 a is fixedly mounted on a rail 640 while second plateengager 600 b is movably mounted on rail 640. Second plate engager 600 bis preferably glidably mounted on rail 640 with a fixed orientation suchthat it can be advanced toward first plate engager 600 a to compress thecompression plate apparatus 300. Second plate engager 600 b is held in afixed orientation due to the position of groove pin 644 extendingthrough or from rail 640 which is positioned in groove 634 of firstplate engager 600 a. Note that as shown below in reference to FIG.15A-15C, the attachment actuation device need not be part of the sameapparatus with the anvil pull engager and the cutter.

Anvils

As discussed above in reference to anvil 210, the anvil provides asurface at its engaging end for engaging the cutter. The engaging end isalso in direct contact with the blood vessels intima at the anastomosissite when the anvil abuts the receiving blood vessel wall. The term“anvil” is meant to encompass objects with the characteristics describedherein which present at least one surface that is adapted to engage acutter.

The anvil is preferably sized at its engaging end to have a greatercross-sectional area than a cross-sectional area defined by theperimeter of the cutting edge of the cutting device such that portionsof the engaging end of the anvil extend beyond the cutting edge when thecutting device engages the anvil and forms the first vessel opening.This size differential is particularly useful for cutting when thecutting device is a mechanical cutter or knife as it permits theanastomosis fenestra or vessel opening to be formed through the actionof the cutting edge 414 be pressed against engaging end 212. This is asignificant improvement over conventional cutting techniques thatinvolve the external positioning of an anvil into the lumen of a vesselthat is smaller than the cutter so that the vessel is cut as the cutterpasses over the anvil. Such conventional cutting techniques operate muchlike a typical hand held paper punch used for forming holes by pushing acutter over an anvil Just like paper punches such vascular punches oftenfail to fully make the cut and leave a portion attached. The connectivetissue in blood vessels in combination with the moist condition of theblood vessels further limit the effectiveness of such prior art cuttingtechniques. More particularly, cutting a moist highly interconnectedmaterial by squeezing it between the anvil and the cutter often resultsin part of the tissue merely slipping between the anvil and the cuttersuch that a portion is still attached.

In addition to cutters that are essentially tubular knives, additionalcutting devices are described below in the section entitled CuttingDevices. These cutting devices include devices that utilize a radiationsource, such as a surgical laser, that emit radiation of the appropriatecharacteristics to open the anastomosis fenestra in the receiving bloodvessel wall. Such cutting devices that utilize radiation to ablate thevessel wall are also preferably used with an anvil having across-sectional area at its engaging end that is larger than thecross-sectional area defined by the perimeter of the cutting edge of thecutting device. While it is useful to have an anvil with an engaging endthat extends beyond the cutting edge or the perimeter of the portionthat cuts through the use of radiation to localize the impact of thecut, such as minimization of heat transfer, the engaging end need notnecessarily be larger for use with such cutting devices.

Anvil 40 is preferably made of a puncture resistant material that canwithstand the abrasive action of a cutting element. For example, anvil210 may be formed from a hard plastic material such as Delrin® acetalresins or a high density polyurethane or from a metal such as stainlesssteel in order to withstand the abrasive action of a cutting device orof a sharp pointed end. When cutting the anastomosis fenestra withradiant energy, the anvil of this invention is preferably coated withradiation absorbing material that prevents radiation scattering. Suchcoated anvil embodiments are hereinafter referred to as “laser shieldedanvils”.

FIGS. 7A-7D provides examples for several embodiments of the anvil ofthis invention. A line 248 is a visual aid drawn through anvils 210 a-dto clearly indicate that the portion of the anvil extending from line248 to the anvil pull is the engaging end 212 a-d. Engaging ends 210 a-care all spherical engaging ends like spherical engaging end 212 of anvil210. Note that these spherical engaging ends are essentially ahemisphere at the side of the anvil proximal to the anvil pull 230. Whenthe cutting device is cylindrical and is configured such that it permitspart of the spherical engaging end of the anvil to be positioned in thechamber 420 then the cutter self centers on a spherical engaging end.

Landing 214 of anvil 210 is also useful feature when the anvil is usedin combination with a compression plate apparatus or some of the meansfor joining a portion of the first vessel that defines the first vesselopening to a portion of a second vessel that defines a second vesselopening such that the first vessel and the second vessel are anastomosedtogether and are in fluid communication. As noted above, landing 214 isessentially the surface of the cylindrical portion of anvil 210. When ananvil with a spherical engaging end and cylindrical landings such asanvil 210 is used with a compression plate apparatus such as apparatus300 then the spherical engaging can extend through first compressionplate opening 320 a and into the apparatus while landing 214 abuts thewall of blood vessel 20 against holding tabs 314 a. The tolerancebetween landing 214 and holding tabs 314 a is such that landing 214initially rests against holding tabs 314 a until sufficient force isapplied to pull anvil 210 through compression plate apparatus 300. Asshown in FIGS. 4B-4C and FIGS. 12D-12E, landing 214 assists in theeversion process before anvil 210 is pulled through the compressionplate apparatus. More particularly, landing 214 enables the portion 26defining the first vessel opening 24 to be everted as everted portion 56of graft vessel 50 is pushed against portion 26. As everted portion 56pushes against portion 26, portion 26 curls up and over holding tabs 314a. This process preferably fully everts portion 26, however,satisfactory results are obtained even if portion 26 is only partiallyeverted.

FIG. 7A depicts an anvil 210 a that has a landing 214 a which isslightly flared so that it tapers toward the engaging end 212 a. Thismay further assist in achieving a desired eversion. FIG. 7B shows ananvil 210 b having a rounded flange at its terminal end 218 which mayalso assist in everting the portion of the vessel that defines thevessel opening.

FIG. 7C depicts an anvil 210 c that has a spherical engaging end 48opposite from a tapered terminal end. As explained below, many featuresdescribed herein in reference to an intraluminally positioned anvilapparatus also relate to an externally directed anvil apparatus. Asshown in FIGS. 16A-16E, FIGS. 17A-17C, FIGS. 18A-18B, FIGS. 19A-19B, ananvil 210 may be inserted though a wall of a blood vessel at aninsertion opening that has been selected as an anastomosis site andpositioned in a lumen of the first vessel with the anvil pull 230extending through the insertion opening of the blood vessel. Note thatsuch use may require some modifications. For example, use of an anvilwith a tapered end such as tapered end 218 c minimizes the size neededfor the insertion opening since the vessel wall can stretch as the taperof the anvil increases.

FIG. 7D depicts an anvil 210 d having an elliptical engaging ends thatis adapted to receive a cutter with a corresponding ellipticalconfiguration for the formation of elliptical openings in vessels. Asdescribed in greater detail in reference to FIGS. 14A-14C and FIGS.16A-16B, it is often necessary to attach vessels in a nonperpendicularconfiguration such that it is Y-shaped instead of T-shaped. Like anvil210 c, anvil 210 d has a tapered terminal end for ease in use as anexternally positioned anvil apparatus. While reference is made tospherical engaging ends it should be noted that noncircular engagingends that are convex such as the elliptical engaging end of anvil 210 dmay also be utilized to achieve the desired eversion, particularly whenthe anvil has an appropriately configured landing.

FIG. 8 depicts another embodiment of an anvil apparatus 200′. Anvilapparatus 200′ has a positioning stem 240′ used to push anvil 210 to theanastomosis site through a positioning catheter 140′. Accordingly, whenusing anvil apparatus 200′ it is not necessary to utilize a piercingcatheter or a piercing wire. Note also that anvil apparatus 200 has ananvil pull with a sharp piercing end 232′ instead of a blunt or roundedpenetration end 232 like anvil apparatus 200. The pointed configurationof piercing end 232′ enables it to make initial piercing 15 in the wallof vessel 20 by puncturing the wall from its intima outward withoutcausing undue tearing around the puncture. Piercing end 232′ is thenpulled from the outside of receiving blood vessel 20 just likepenetration end 232 of anvil pull 230. Note that anvil pull 230 of anvilapparatus 200 may have either a distal end that is rounded or blunt likepenetration end 232 or sharp such as piercing end 232′.

Anvil apparatus 200′ is not shown with a stopping element such asstopping element 236 of anvil apparatus 200. Anvil apparatus 1000 inFIG. 17A also is not shown with a stopping element as its anvil pull andanvil are integral. However, anvil apparatus 200 may utilize a stoppingelement such as the stopping elements discussed in detail in the abovesection entitled Methodology Overview. For embodiments with an anvilthat is nonintegral with the anvil pull, the stopping element holdsanvil stationary relative to the anvil pull such while withstanding apressure exerted at the engaging end of the anvil due to the resistanceexerted by the receiving blood vessel wall being distended by the anviland the pressure of the cutting device against the engaging end.

Anvil apparatus 200′ is positioned through positioning catheter 140′ byfirst introducing anvil pull 230′ and then pushing positioning stem.When the anastomosis site is reached, then anvil pull 230′ is pushed outof positioning catheter 140′ and through initial piercing 15 until theengaging end 212′ of anvil 210′ abuts the interior of the wall of vessel20. Catheter 140′ may be positioned within lumen 28 of blood vessel inthe same manner as catheter 140.

Distal end 142′ may be adapted for providing a lateral exit for piercingend 232 of anvil pull 230. Distal end 142′ may have a deflecting surfaceand a lateral aperture that guides piercing end 232 towards the intimaof receiving blood vessel 20. Because piercing end 232 is very sharp,such deflecting surface is preferably a puncture and abrasion resistantsurface. In addition, distal end 142′ may have an appropriate marker forimaging the orientation of the aperture at distal end 142 and/or theposition of distal end 142 itself. Such radio-opaque markers can be anyof the radio-opaque markers known in the practice of angiography.Similarly, all of the catheters used in the anastomosis procedure mayhave radio-opaque portions. Anvil pull 230′ is typically radio-opaqueitself, although very thin embodiments of this wire are preferablycoated with a material such as gold or a biocompatible barium-containingsubstance to make them more visible. Catheter distal end configurationsfor directing outwardly an elongated member have been disclosed in U.S.Pat. Nos. 4,578,061, 4,861,336, 5,167,645, 5,342,394, and 5,800,450,which are hereby incorporated by reference in their entirety.

The dimensions of any of the embodiments of the anvil of this inventionare determined by the size of the lumen of the receiving vessel and bythe dimension of the passage that will ensure the fluid communicationbetween the graft vessel and the receiving vessel after they have beenanastomosed. These dimensions are typically chosen or known in the art.For example, when a graft vessel of about 4 mm in diameter is to beanastomosed to a receiving blood vessel which has an approximate lumendiameter of about 8 mm, the diameter of anvil at its widest may rangefrom about 3 mm to about 6 mm. So for anvil 210, the diameter at landing214 may range from about 3 mm to about 6 mm for use in such a vessel.However, the anvil may have any suitable size that enables it to bepositioned as needed. Note that the anvil is preferably designed so thatthe blood flow through the receiving blood vessel will preferably not beinterrupted during the anastomosis. However, the design can be such thatthe blood flow is interrupted when this feature is desired.

FIGS. 9A-9B, FIGS. 10A-B and FIGS. 11A-B each depict an anvil apparatuswith an anvil that is deployable after reaching the anastomosis sitesuch that they have an expanded size when needed. FIGS. 9A-9B and FIGS.10A-B depict mechanically deployable anvils while FIGS. 10A-10B depict achemically deployable anvil.

The anvil apparatus depicted in FIGS. 9A-9B is identical to that ofanvil apparatus 200 except anvil 210 is smaller and two flexible anvilsheaths 260 a-b are positioned on anvil pull 230. Flexible anvil sheaths260 a-b are adapted to be nested as shown in FIG. 9B once the wall ofvessel 20 is encountered to cause the flexible anvil sheaths 260 a-b tobe dislodged from their positions on anvil pull 230. Anvil sheaths 260a-b may be retained in their spaced positions on anvil pull throughreliance on a tight frictional fit or stops may be utilized to ensurethat the sheaths are not dislodged until desired at the anastomosis sitethrough application of an appropriate amount of force. When nested onanvil 210, flexible sheaths 260 a-b and anvil 230 act together as ananvil. The anvil sheaths may be relatively soft compared to anvil 230 soit may be necessary to treated the anvil sheaths with a punctureresistant material or an abrasion resistant material.

FIGS. 10A-10B depict a flexible anvil 210″ that is narrow when collapsedand becomes wider when its engaging end 212″ encounters the wall ofblood vessel 20. The engaging end 212″ of anvil 210″ is not attached toanvil pull 230, only terminal end 218″ is attached to anvil pull. Sinceanvil 210″ is hollow, it can flex into an expanded or deployed positionwhen engaging end 212″ is pushed toward terminal end 218″.

FIG. 11A depicts a balloon anvil 210′″ in a deflated condition extendingfrom a hollow tubular anvil pull 230″. FIG. 11B depicts balloon anvil210′″ deployed in an inflated condition ready for engagement against theinterior of a vessel at an anastomosis site. Balloon anvil is preferablychemically deployed by being filled with a polymerizable material thathardens in situ. For example, syringe 280 may be coupled to tubularanvil pull 230 to enable a composition to be delivered that includesconventional monomers that rapidly polymerizes in the presence ofappropriate chemical initiators.

For example, the monomers may be suitable acrylates such as urethanedimethacrylate, p-hydroxyphenyl methacrylamide, butane dioldimethacrylate, and bisphenol-A-diglycidyl dimethacrylate (“Bis-GMA”).Examples of appropriate chemical initiators include a wide range ofperoxides, other per components, and other free radical generators. Anappropriate two-part chemical curing system typically includes aperoxide constituent in one part and an amino compound in another.Exemplary peroxides include benzoyl peroxide, 2-butanone peroxide,lauroyl peroxide and tert-butyl peroxide. Examples of amino compoundsinclude dimethylamino ethyl methacrylate, triethyl amine,2-dimethylamino ethanol, diethylamino ethyl methacrylate, trihexylamine, N,N-dimethyl-p-toluidine, N-methylethanolamine, and2,2′(p-tolyimino) diethanol.

After the polymerizable material, the mixture of monomers and chemicalinitiators, has been delivered into balloon anvil 210′″ then it isnecessary to wait for the material to polymerize such that anvil 210′″is hard. As shown in FIG. 11B, once the polymerizable material hashardened then anvil pull 230″ is anchored in polymerized material 222and polymerized material 222 is surrounded by balloon 220. Since anvilpull 230″ is anchored in polymerizable material 222, balloon anvil 210can be used in a cutting process without regard to the softness ofballoon 220. More particularly, if a cutter 400 presses through balloon220 then it merely rests on the exposed polymerized material 222 withthe cut portion of blood vessel 20 and is removed along with the entireanvil apparatus 200′″.

Balloon anvil may also be merely inflated with gas or an appropriatefluid; however, such a balloon anvil is best utilized with embodimentsthat do not require the anvil to be puncture resistant such as a cuttingdevice that uses radiation followed by steps such as gluing, welding orsoldering to join the vessels together. Of course, it may be necessaryto treat the engaging end of a balloon anvil such that it is lasershielded by placing a laser shield material at the engaging end of theballoon anvil. One example of a laser shield material is a shieldconsisting of a sandwich of polymethylmethacrylate and tinfoil that isknown to provide corneal and retinal protection from inadvertent injuryduring argon, Nd-YAG or dye laser treatment at the tested laser poweroutputs. Similarly, the balloon anvil may be treated with an appropriatematerial such that it is puncture resistant or distortion resistant.

The balloon may also be a puncture resistant balloon. Puncture andscratch resistant balloons have been disclosed in U.S. Pat. Nos.5,766,158, 5,662,580, 5,620,649, 5,616,114, 5,613,979, 5,478,320,5,290,306, and 5,779,731, which are hereby incorporated by reference intheir entirety. In still another embodiment of this invention, the anvilof this invention can be embodied by the combination of a balloon and apuncture resistant balloon sheath. A balloon plus balloon sheathcombination has been disclosed in U.S. Pat. No. 5,843,027 which ishereby incorporated by reference in its entirety.

In summary, the anvils are configured in a way such that it effectivelycooperates with the cutting device to form the opening of theanastomosis fenestra. The anvils also cooperates in the eversion of theedge of the anastomosed fenestra. Furthermore, the anvil of the presentinvention is configured so that it can abut the receiving blood vesselwall at the anastomosis site from the intraluminal space of such bloodvessel. In addition, the anvil of this invention is configured so thatit effectively cooperates with the compression plate apparatus in thejoining of the anastomosed structures. The anvils disclosed herein areall examples of anvil means for engaging the interior surface of a firstvessel at an anastomosis site. The anvil means that are part of anintraluminally directed anvil apparatus are more specifically anvilmeans for engaging the interior surface of the wall of a first vessel atan anastomosis site wherein the anvil means is sized to pass within thelumen of the first vessel from an insertion site to a remotely locatedanastomosis site.

Compression Plate Apparatus

As indicated above, the plates are configured so that they providesupport to the everted openings of the anastomosed structures andfacilitate the eversion of the receiving blood vessel, the vessel towhich another vessel is being attached that has been everted beforeinitiating the procedure. The compression plate apparatus also eliminatethe need for skilled suturing. Use of the compression plate apparatusmakes anastomosis procedures more efficient in a reliable manner.Additionally, the compression plate apparatus holds the anastomosedstructures in an effective leak proof contact engagement.

In each compression plate, the side which is in contact with the evertedcontour of the anastomosed structure is described as the anastomosisside. In the practice of an anastomosis according to this invention,compression plates are used in a way such that the anastomosis sides ofthe two compression plates are opposite to each other. Preferredembodiments of compression plates have a generally annular shape withinterior openings which have a generally circumferential contour; theinternal diameter of each one of these openings is such that thecorresponding portion of the vessel to be anastomosed can fit therein.Typically, this internal diameter is approximately equal to, or slightlygreater than, the external diameters of the corresponding portion of thevessel to be anastomosed. An internal diameter slightly greater than theexternal diameter of the corresponding portion of the vessel to beanastomosed is preferred. With this internal diameter, the compressionplate does not pose a significant obstacle to the periodic dilation thatthe vessel is subject to as a consequence of the characteristics of thefluid flow that circulates through the anastomosed structures.

There are two primary embodiments disclosed herein including the guidedcompression plate apparatus 300 shown in FIGS. 3A-3B, FIGS. 4A-4E, FIGS.5A-5B, FIGS. 6C-6E and the snap-fit compression plate apparatus 300′shown in FIGS. 12A-12G. A variation of compression plate apparatus 300is also shown at 300″ in FIG. 13 to show that a compression plateapparatus can also be used for joining vessel together in anonperpendicular orientation. Each plate has an opening 320 a-b that isgenerally round, however, as shown in FIG. 13, the openings may also beellipsoidal, ovoid, or have other noncircular configurations. Thecompression plate apparatus can be used in combination with either anintraluminally directed anvil apparatus or an externally positionedanvil apparatus.

Compression plate apparatus 300 is best viewed in FIGS. 3A-3B.Compression plate apparatus 300 has a compression plate 310 a isreferred to as a first compression plate or a receiving vesselcompression plate while compression plate 310 b is referred to as asecond compression plate or an attaching vessel compression plate. Asdiscussed above, compression plate apparatus 300 is shown in FIG. 3Abefore graft vessel 50 has been loaded onto holding tabs 314 b of secondcompression plate 310 b while FIG. 3B shows graft vessel 50.

Compression plates 310 a-b are provided in the exemplary embodimentshown in FIG. 3A with a plurality of holding tabs 314 a-b respectivelyprotruding from opposing anastomosis sides 322 a (not shown) and 322 bof compression plates 310 a-b. More particularly, holding tabs 314 a-bextend respectively from rings 312 a-b of compression plates 310 a-b.Holding tabs 314 a-b are intended to hold the everted contours of thestructures being anastomosed. Each one of holding tabs 314 a-b has abase that integrally extends from the anastomosis side of the ring 312a-b of the corresponding plate at 313 a-b and that terminate at roundedtips 316 a-b. Distal tips 316 a-b are preferably rounded as shown tominimize the potential for penetration. However, in some embodiments,the distal tips may be pointed, for example, when holding a graftvessel. Holding tabs 314 a-b are typically rather rigid, however, theymay also be designed to elastically bend in such a way that the distaltips of such holding tabs slightly swing about their respective bases.Such a bending action may be caused by the displacement through any ofopenings 320 a-b defined by holding tabs 314 a-b, more particularly thedistal tips 316 a-b of holding tabs 314 a-b.

The number of holding tabs and their spacing may be varied as need aslong as the portions of the vessels defining the vessel openings can bemaintained in an everted orientation. For example, the plurality ofholding tabs may include sixteen holding tabs as shown in FIG. 3A.However, smaller amounts may also be utilized, for example there may beonly six to ten holding tabs.

Holding tabs such as holding tabs 314 a-b can have a plurality ofshapes. The holding tabs preferably used in embodiments of thisinvention are wider at the base and so configured as to extend into adistal rounded tip at the end opposite to the base. Although holdingtabs 314 a-b can be distributed in a variety of arrays, a generallyregular distribution on the anastomosis sides of the compression platesis preferred.

Each of the holding tabs shown in the embodiment schematically depictedin FIG. 1 is attached at its base 316 a-b at the inner peripheries 313a-b of rings 312 a-b. However, the bases 316 a-b may also extend fromother locations of the rings. For example, the bases 316 a-b may extendfrom rings 312 a-b between the outer peripheries 311 a-b and the innerperipheries 313 a-b or perimeter on the anastomosis sides 322 a-b ofeach annular compression plate.

Although, it is not necessary for the holding tabs in each compressionplate to be oriented relative to the holding tabs in the othercompression plate in a mating configuration, it is preferred. Whenreferring to the relative configuration of the holding tabs in opposingcompression plates, the terms “mating or mated configuration” describe aconfiguration in which each one of the holding tabs in a compressionplate can generally fit in the space between two neighboring holdingtabs in the opposing compression plate when such compression plates areclose enough. As shown by the phantom lines in FIG. 3A, holding tabs 314b are offset from holding tabs 314 a such that as the plates are broughttowards each other each holding tab 314 b is positioned opposite fromthe spaces between holding tabs 314 a in a mated configuration. When thecompression plates are brought together just close enough for the tips316 a-b to be in the same plane, then the everted tissue is held inplace and the anastomosis is secure. Failure to bring the compressionplates sufficiently close together such that the tips 316 a-b aresignificantly close together risks the potential loss of the tissue thathas been captured and everted onto holding tabs 314 a-b. Note that eachholding tab 314 b is shown just barely entering into an opposing spacebetween adjacent holding tabs 314 a. Of course, the compression platesmay be designed for further compression such that holding tabs 314 bfurther enter the space between adjacent holding tabs 314 a. However,the compression plates are preferably designed such that the plates arebrought together without penetrating blood vessel 20 or graft vessel 50.Note that guides 330 maintain the orientation of the compression platesso that the respective teeth have the preferred mating configuration.

An example of a suitable compression is provided by a compression plateapparatus having holding tabs with lengths of 0.045 inches (0.1143 cm)that has a distance between the anastomosis sides 322 a-b of rings 312a-b of 0.090 inches (0.2286 cm). Compression down to only 0.10 inches(0.254 cm) for such a compression plate apparatus is generallyinsufficient to hold the anastomosed tissues. The plates may be furthercompressed such that the distance between the anastomosis sides 322 a-bis 0.080 inches (0.2032 cm) or 0.070 inches (0.1778 cm) to bring vessel20 and vessel 50 even closer together. However, as noted above, it ispreferable to avoid pushing through the vessels. The compression plateare accordingly designed to permit compression down to the ideal spacingbetween the anastomosis sides while providing holding tabs that are longenough to capture the tissue in an everted configuration.

The holding tabs such as holding tabs 314 a-b are preferably configuredin a way such that they are not exposed to blood flowing through theanastomosed structures. Some embodiments of this invention are providedwith holding tabs that are coated with a biocompatible non-thrombogenicmaterial to prevent the formation of thrombi if such holding tabs or anyportion thereof becomes exposed to blood flow. An example of suchmaterial is teflon.

Holding tabs of a variety of shapes which are distributed in varyingnumbers and arrays on the anastomosis sides of compression plates 310a-b and equivalents thereof are exemplary embodiments of means forholding a portion of a vessel that defines the vessel opening. Asindicated above, the holding tabs preferably hold the portion of thevessel that defines the vessel opening in a manner such that the portiondefining the first vessel opening is at least partially everted and isnot penetrated. The holding tabs disclosed herein are all examples ofholding means for holding a portion of a first vessel that defines avessel opening in manner such that the portion defining the vesselopening is at least partially everted and is preferably not penetrated.

As indicated above, guides 330 permit the relative approach of these twoplates as compression plate 310 b slides along guides 330 towardscompression plate 310 a. More particularly, guides 330 enablecompression plates 310 a-b to be brought together in a manner such thatsecond compression plate 310 b is moved in a fixed parallel orientationrelative to first compression plate 310 a. Additionally, guides 330 arepositioned relative to holding tabs 314 a-b and have a length thatpermits graft vessel 50 to be loaded onto holding tabs 314 b and then bebrought into contact with blood vessel 20. Stated otherwise, theconfiguration of guides 330 enables first vessel opening 24 and secondvessel opening 54 to be initially spaced apart and opposite from eachother and then to be advanced toward each other as second compressionplate 310 b is moved with graft vessel 50 held on the holding tabs 314 bwhile blood vessel 20 is held by holding tabs 314 a of compression plate310 a. As best shown in FIGS. 4A-4D, movement of second compressionplate 310 b toward first compression plate 310 a brings the portion 56of graft vessel 50 that defines the second vessel opening 54 intocontact with the portion 26 of blood vessel 20 that defines the firstvessel opening 24 such that the blood vessel and the graft vessel areanastomosed together.

Compression plate 310 b is slidably mounted on guides 330 at guideapertures 334. To slide compression plate 310 b along guides 330, eachone of ends 332 of guides 330 is introduced through one of guideapertures 334 of compression plate 310 b. Ends of guides 330 opposite toends 332 are attached to ring 312 a of compression plate 310 a, however,guides 330 may also integrally extend from ring 312 a.

As shown, the compression plate apparatus preferably has a plurality ofguides. While compression plate anastomosis 300 is shown with fourguides 330, other embodiments may have other configurations such thatthe plurality of guides includes, for example, three to six guides.Further, other embodiments may have less than three or more than sixguides. It is even possible to have only one guide. Although guides 330can be distributed in a variety of arrays, a generally regulardistribution is preferred in embodiments with more than one guide.

When compression plates 310 a-b are in close proximity to each other atan anastomosis site providing support to the anastomosed structures,terminal ends 332 of guides 330 can extend away from compression plates310 a-b to an extent such that the protrusion results in the presence ofan undesirable feature in the immediate neighborhood of the anastomosissite. To solve this problem, embodiments of the compression platedevices of this invention are provided with guides 330 which can beappropriately shortened by removing an appropriate length of terminalends 332. In some embodiments, terminal ends 332 are manufactured with amaterial which dissolves after an appropriate time following theanastomosis. In other embodiments, guides 330 are made of a materialthat can easily be clipped to a desired length, thus eliminatingterminal ends 332 as shown in FIG. 4D. In other embodiments, guides 330can be provided with notches or some other localized weakened structuralfeature which facilitates the easy removal of terminal ends 332 atdesired distances with respect to plate 310 a. Still other embodimentscan be provided with terminal ends 332 that can easily bend to an extentsuch that undesirable protrusions are eliminated.

The guides may have a variety of lengths and be distributed in varyingnumbers and arrays. The guides may also extend from one or both of thecompression plates at any appropriate location. However, the guides arepreferably situated such that the portion 26 defining the blood vesselopening 24 and the portion 56 defining the graft vessel opening 54 arejoined without being penetrated as the first vessel and the secondvessel are anastomosed together. The guides disclosed herein areexemplary embodiments of means for guiding the movement of onecompression plate with respect to the other compression plate. Moreparticularly, the guides disclosed herein are examples of means forguiding the movement of one compression plate relative to the other suchthat one compression plate moves in a fixed parallel orientationrelative to the other compression plate.

Guide apertures 334 are sized to frictionally engage guides 330 in amanner such that compression plate 310 b does not inadvertently slide onguides 330, particularly not after being compressed towards compressionplate 310 a. In the absence of a suitable frictional engagement,compression plate 310 b may slide away from compression plate 310 a topotentially jeopardize the leak-proof character of structures heldtogether by the compression plates. An undesired separation could becaused, for example, by an expansion of the anastomosed structures atthe anastomosis site, caused in turn by the pressure exerted by thefluid circulating therethrough.

When second compression plate is formed from plastic, the desiredfrictional engagement is generally achieved whether guides 330 are madefrom metal or plastic. However, when second compression plate is formedfrom metal and the guides are also metal, it is preferable to utilize analternative frictional engagement. For example, FIG. 5A showscompression plate apparatus 300 with an optional holding ring 340 thathas a friction coupling with guides 330 through its guide orifices 346.Holding ring 340 is provided with opening 348 whose internal diameter ispreferably at least equal to that of the opening 220 b of compressionplate 310 b. The frictional engagement of holding ring 340 with guides330, like the frictional engagement described above for guide apertures334 with guides 330, is such that expansion of the anastomosedstructures can not separate compression plates 310 a-b with respect toeach other when holding ring 340 is in contact engagement with exteriorside 324 b (not shown) of compression plate 310 b opposite to itsanastomosis side 322 b. The holding ring may, for example, be formedfrom nylon.

Other embodiments of this invention are provided with differentfrictional engagements that are designed to prevent compression plate310 b from significantly moving away from compression plate 310 a. Forexample, guides 330′ of compression plate apparatus 300″ in FIG. 13 havebarbs 336. These frictional engagement configurations described aboveenable the compression plates to be approached to a desired relativeseparation and maintained at that separation. This feature also permitsthe control of the pressure applied to the everted tissue of theanastomosed structures and the compression of the plates in stages sothat they are approximated in a controlled manner.

These frictional engagements are all examples of means for locking thecompression plates together. More particularly, guides that engageappropriately sized apertures 334 of second compression plate 330 b forfrictional engagement, a holding ring 340 that has guide orifices 346sized to fractionally engage a guide 330, and guide barbs 336 forirreversible advancement of second compression plate 310 b as the guideextends through guide apertures 334 of second compression plate 310 bare all examples of means for locking the compression plates together.Note that when the frictional engagement is achieved through reliance onguides that extend from a first compression plate and that pass thoughappropriately sized apertures in the second compression plate then itcan be said that the first compression plate and the second compressionplate have means for locking the compression plates together. Anadvantage of such locking means that are part of the first and secondcompression plates is that it is not necessary to separately attach thelocking means to the compression plate apparatus after it has been usedto anastomose the vessels.

The compression plate apparatus is preferably used for vascularanastomosis, however, the present invention is not limited to such use.Nor is the compression plate apparatus limited to use with anyparticularly sized vessel. For example, vessels may be joined withdiameters ranging from about 2 mm to about 20 mm, but there is nofundamental limitation for using embodiments of this invention withgraft vessels with diameters less than 2 mm.

A variety of techniques known in the art can be used to manufacturecompression plates within the scope of this invention depending on thematerial used. Compression plate apparatus 300, 300′ and 300″ can beformed from a plastic material such as nylon or from metals such astitanium or nickel/titanium alloys. Stainless steel can be used but isnot preferred. Additionally, one plate may be formed from a metal whilethe other is formed from plastic. In addition to molding the plates,when the plates are formed from metal, the plate may be cut from a diskin a flat configuration and then the holding tabs can be bent intoposition.

Although guides such as guides 330 provide a convenient structuralelement for appropriately orienting and approaching the compressionplates of this invention relative to each other, the appropriateorientation and relative displacement of the compression plates can beachieved in other ways that accomplish the same effects as discussed forexample in reference to compression plate apparatus 300′. Thesedifferent ways of providing the appropriate relative orientation of thecompression plates and the relative displacement are within the scope ofthis invention. For example, a device used to hold the compressionplates as shown in FIG. 6D-6E, FIG. 12C-12G, and FIG. 16C can providethe appropriate support for orienting and displacing the compressionplates relative to each other. Similarly, the cutting device may beconfigured to provide the appropriate orientation.

FIGS. 12A-12B provide a perspective view of snap-fit compression plateanastomosis apparatus 300′. Like guided compression plate apparatus 300,snap-fit compression plate apparatus 300′ has two opposing compressionplates including a first compression plate 310 a′ and a secondcompression plate 310 b′.

First compression plate 310 a′ has a ring 312 a′ with an inner periphery311′ and an outer periphery 313′. A plurality of holding tabs 314 a′extend from ring 312 a′. Like holding tabs 314 a, each holding tab 314a′ has a base 316 a′ and terminate at a distal rounded tip 315 a′. Thebase of each tab is preferably integral, as shown, with ring 312 a′.Each holding tab 314 a′ extends at its base from ring 312. Moreparticularly, each holding tab 314 a′ extends from inner periphery 311′from exterior side 324 a′ toward anastomosis side 322 a′ (not shown).

Holding tabs 314 a′ extend either perpendicularly from ring 312 a′ offirst compression plate 310 a′ or curve inward from exterior side 324 a′of ring 312 a′ of first compression plate 310 a′ such that distalrounded tips 316 a′ of holding tabs 314 a′ are nonperpendicularlyoriented relative to exterior side 324 a′ of ring 312 a′ of firstcompression plate 310 a′. Like holding tabs 314 a, holding tabs 314 a′may have varying configurations and various numbers of holding tabs maybe utilized.

First compression plate 310 a also has a plurality of locking arms 350extending from outer periphery 311 a′. Locking arms 350 are adapted tolock with a locking extension 360 projecting from second compressionplate 310 b′. Engagement of these locking components enables compressionplates 310 a′-310 b′ to lock together such that the portion 26 definingthe first vessel opening 24 and the portion 56 defining the secondvessel opening 54 are joined without being penetrated as the firstvessel and the second vessel are anastomosed together.

Locking arms 350 have a length that enables them to lock around lockingextension 360 in a manner such that the portion defining the firstvessel opening and the portion defining the second vessel opening areheld together without being damaged in a manner that causes theanastomosis to fail. Each locking arm 350 has a pivot portion 352 thatterminates at a grasping portion 354. Grasping portion 354 is preferablya curved portion of locking arm 350 directed annularly inward.

Second compression plate 310 b′ has a second compression plate opening320 b′, or more precisely, an anastomosis side opening 320 b′, definedby a holding surface 364. Second compression plate opening 320 b′ mayalso be described as being defined by rim 368 which is the point atwhich holding surface joins tubular portion 370. Holding surface 364extends radially downward at an angle from anastomosis side opening 320b′ and terminates at locking extension 360 such that second compressionplate 310 b′ flares in diameter from second compression plate opening320 b′ down to locking extension 360. Locking extension 360 has twosurfaces, a flaring surface 362 that is continuous with holding surface364 and a locking surface 366 shown in FIG. 12C-12G. While lockingextension is shown having a flaring surface 362 that is a continuousextension of holding surface 364, these surfaces may also be distinct.

Holding surface 364 has a configuration that permits the portion of thesecond vessel 50′ defining the second vessel opening 54′ to be evertedonto holding surface 364 as shown in FIG. 12B. The vessel shown in FIG.12B everted on holding surface 364 is an autologous or heterologousblood vessel 50′. Of course, a graft vessel like vessel 50 can also beused, however, vessel 50′ is identified as being autologous orheterologous in order to depict the use of vessels that are notartificial. Everted portion 56′ of vessel 50′ is preferably adhered ontoholding surface 364 through the use of an appropriate adhesive such asthose described above in the Background section or attached through theuse of stay sutures or other means for holding vessel in an evertedposition. While holding surface is shown extending radially downward atan angle from the second compression plate opening, it may have anysurface that is suitable for everting the portion of vessel 50′ thatdefines opening 54′ and for holding the everted portion 56′.

As shown in FIG. 12B, tubular portion 370 is adapted to receive vessel50′ through exterior side opening 372 such that graft vessel can passthough anastomosis side opening 320 b′ and be everted onto holdingsurface 364. As shown in FIG. 12G, exterior side opening 372 is definedby tubular portion 370 and locking surface 366. The farther that lockingsurface 366 extends from exterior side opening 372 the greater thedistance between vessel 50′ and grasping portion 354 once theanastomosis is complete. Tubular portion 370 may have an extension toprovide further protection for vessel 50′ against contact with graspingportion 354. Tubular portion 370 may have a slanted orientationcorresponding to the angled orientation of holding surface 364. However,tubular portion is preferably configured such that it has parallel sidesas such a configuration enables the barrier between grasping portion 354of locking arms 350 and vessel 50′ to be maximized.

Holding tabs 314 a′ are additional examples of holding means for holdinga portion of a first vessel that defines a vessel opening in manner suchthat the portion defining the vessel opening is at least partiallyeverted and is preferably not penetrated. Holding surface 364 is a alsoan example of holding means for holding a portion of a first vessel thatdefines a vessel opening preferably in manner such that the portiondefining the vessel opening is at least partially everted and ispreferably not penetrated.

FIGS. 12C-12G provide a sequential presentation of the steps involved inutilizing snap fit compression plate apparatus 300′ as an anastomosisfenestra is formed in first vessel 20 and as the compression plates arebrought together to approximate vessel 20 and vessel 50. The sequentialsteps depicted in FIGS. 12C-12G are similar to steps depicted in FIGS.4A-4D for the use of guided compression plate apparatus 300. However,FIGS. 12C-12G also show the use of attachment actuation device 600′having a first plate engager 600 a′ and a second plate engager 600 b′.Attachment actuation device 600′ is slightly different from attachmentactuation device 600, which is described in reference to FIGS. 6A-6E indetail in the section entitled External Anastomosis Operator, in that itis not necessary to utilize the optional adapters 610 a-b since firstand second compression plates 310 a′-310 b′ are directly engaged. Eachplate engager 600 a′-600 b′ has a component or a portion that directlycontacts the plate in a configuration such that the plate is held in alocked manner or such that the plate can be moved. A plurality of screws615 a′ lock first compression plate 310 a′ in place while extension 615b′ of second plate engager 600 b′ pushes second compression plate 310b′. First compression plate 310 a′ may have recesses for receivingscrews 615 a′.

FIG. 12C depicts anvil 210 extending through first compression opening320 a with its landing 214 abutting first holding tabs 314 a whilecutter 400 and second compression plate are opposite spherical engagingend 212 with anvil pull 230 extending through cutter 400. FIG. 12Ddepicts cutting edge 414 pressing against spherical engaging end 212above the portion where spherical engaging end terminates at landing214.

FIG. 12E depicts compression plate apparatus 300′ as it is beingcompressed and as portion 26 defining vessel opening 24 is beingeverted. More particularly, compression plate 310 b′ has been movedtoward compression plate 310 a′ as second plate engager 600 b′ is pushedtoward first plate engager 600 a′. Note that the everted portion 56′ ofgraft vessel 50′, more particularly the portion 57′ opposite from therim 368, is urged against portion 26 that defines first blood vesselopening 24 in a manner such that portion 26 is being everted. Thiseversion process is augment by landing 214 of anvil 210 which allowsportion 26 to rest on landing 214 and be plowed upward by evertedportion 56′. The length of portion 26 is sufficient for this eversionprocess since vessel 20 was distended and pulled into the snap-fitcompression plate apparatus by the action of anvil 210. FIG. 12E alsodepicts grasping portion 354 sliding on flaring surface 362 as pivotportion 352 extends radially outward.

FIG. 12F depicts portion 26 fully everted on holding tab 314 a′ suchthat portion 27 opposite from rounded tip 316 a′ is held in contact withthe portion 57′ of vessel 50 opposite from rim 368. After compressionplate apparatus 300′ has been compressed to join portion 26 of bloodvessel 20 that defines first vessel opening 24 to portion 56′ of secondvessel 50′ that defines graft vessel opening 54′ then first vessel 20and second vessel 50 are anastomosed together and are in fluidcommunication. Anvil apparatus 200 and cutter 400 have been removed uponthe completion of the procedure through lumen 58 of graft vessel 50.More particularly, once the anastomosis is completed then anvil pull 230is pulled so that it draws anvil 210 through openings 320 a, 320 b′ and372 of compression plate apparatus 300′ such that anvil apparatus 200 isremoved along with cutter 400 through lumen 58′. FIG. 12G depicts vessel20 anastomosed to vessel 50′ after attachment actuation device 600′ hasbeen removed.

The mated locking components of first compression plate 300 a′ andsecond compression plate 300 b′, namely locking arms 350 and lockingextension 366, are adapted to lock the compression plates together suchthat portion 26 defining first vessel opening 24 and portion 56′defining the second vessel opening 54′ are joined without beingpenetrated. Such locking components are an additional example of meansfor locking the compression plates together. Note these locking meansare integral parts of each compression plate so it is not necessary toseparately attached the locking means to the compression plate apparatusafter it has been used to anastomose the vessels.

FIG. 13 depicts another embodiment of a guided compression plateapparatus 300″ which has components that are almost all identical withthose of compression plate apparatus 300 except that the components ofcompression plate apparatus 300″ are oriented for use with anon-perpendicular anastomosis. Note that the end of vessel 50 has beencut at an angle so that it can be attached to a vessel as shown in FIG.14C at an angle. Cutter 400′ is also angled so that it can make a cut ina vessel that is elliptical in configuration. Openings 320 a″-320 b″ arealso elliptical so that the aligned openings of compression plateapparatus 300′, the first vessel opening and the second vessel openingare all elliptical. Guides 330″ do not extend perpendicularly from ring312 a″ like guides 330. Guides 330″ are all parallel to each other andextend nonperpendicuarly from ring 312 a″ so that guide compressionplate apparatus 300″ is shaped like a parallelogram. Guide apertures334″ are also formed with the same angled configuration of guides 330″.This configuration enables compression plates 310 a″-310 b″ to bebrought together in a manner such that second compression plate 310 b″is moved in a fixed parallel orientation relative to first compressionplate 310 a″.

Holding tabs 314 a-b″ may also be configured differently than holdingtabs 314 a-b in order to hold angled noncircular vessel openings. Notethat guides 330″ extend integrally from ring 312″ and are not attached.Another difference is the use of guide barbs 336 to provide forirreversible advancement of second compression plate 310 b″ towardsfirst compression plate 310 a″ as discussed above with regard tofrictional engagements to prevent movement of the plates relative toeach other after anastomosis. Note that while snap-fit compression plateapparatus 300′ is shown being used for joining vessels with openingsthat are generally circular, the same principles shown with regard toapparatus 300″ can also be used to modify apparatus 300′ for use withnoncircular openings.

Compression plate apparatus 300, 300′ and 300″ are all examples of meansfor joining a portion of the first vessel that defines the first vesselopening to a portion of a second vessel that defines a second vesselopening. More specifically, they are examples of means for mechanicallyjoining the portion of the first vessel that defines the first vesselopening to the portion of the second vessel that defines the secondvessel opening. Other examples of means for mechanically joining thevessels include suture thread, staples, clips, and combinations thereof.An example of the use of staples or clips is shown in FIG. 14C.

The joining means also includes means for chemically joining thevessels. Examples of means for chemically joining the vessels includebiocompatible adhesives or glue; solder; biological procoagulantsolution; a combination of a chromophore and solder, and combinationsthereof. These materials are discussed in detail in the Backgroundsection. FIG. 14D depicts such materials being delivered in accordancewith one embodiment.

The joining means also includes radiation-based means for joining thevessels. Examples of radiation-based means for joining the vesselsinclude tissue welding radiation; the combination of substances andradiation for laser sealing, and combinations thereof. The use ofradiation for joining vessels is discussed in detail in the Backgroundsection. FIG. 14D also depicts radiation being delivered to joinvessels.

Cutting Devices

The term “cutter” is used to refer to a tubular knife such as cutter400. Cutter 400 is an example of a “cutting device” which is a term usedto refer to cutters and any other instrument used to form an anastomosisfenestra or opening that does not rely on the application of mechanicalpressure, such as cutting device 400″. While cutters that use aradiation source, such as a surgical laser, that emit radiation of theappropriate characteristics to open the anastomosis fenestra in thereceiving blood vessel wall are useful, cutting devices such as cutter400 are generally less expensive. Cutter 400 is preferably formed fromstainless steel such that it is sufficiently inexpensive to be adisposable, single use item.

These cutting devices disclosed herein are all examples of cutting meansfor forming an opening in the wall of the first vessel at theanastomosis site through engagement with the anvil of an anvil apparatusas an engaging means holds the anvil pull of the anvil apparatus afterreceiving the anvil pull through the cutting means. The cutting devicesengage an anvil to form the vessel opening in any suitable manner. Forexample, the cutting device may be pushed against the anvil, the anvilmay be pulled against the cutter or both may simultaneously occur suchthat anvil is pulled as the cutter pushes against the anvil.

Cutter 400 is shown in numerous drawings, however, FIGS. 6C-6E, show itsfull length and its use in combination with external anastomosisoperator 700. FIG. 6E provides the best view of cutter 400. Cutter 400is shown in FIG. 6B-E as including a tip portion 401 and an extensionportion 402, however, cutter 400 is shown elsewhere as being integral.

Anvil pull 230 is shown in FIG. 6C extending through cutter 400. Cutter400 is hollow so it has a chamber 420 between the sidewalls of cuttingtube 410. Cutter 400 may also have an optional centering core 422 thatextends at least part way though chamber 420. Centering core 422 has acentering conduit 424 that assists in centering anvil pull 230 in cutter400 such that anvil pull 230 is essentially parallel with the sidewallsof cutting tube. Centering core 422 preferably has a tapered access toguide anvil pull 230 into centering conduit 424. Another example of acentering conduit is provided by a centering conduit 424′ of cuttingdevice 400′ shown in FIG. 14D, as discussed below in greater detail.

It is not always necessary for cutter 400 to have a centering core orfor other cutting devices to have a centering core or a centeringconduit. When the engaging end of the anvil is spherical and the cutteris spherical and is configured such that it permits part of thespherical engaging end of the anvil to be positioned in cutter chamber420 then the cutter self centers on the spherical engaging end. Theentire cutting device need not be hollow. For example, cutting device400″ has a recess 428 at its cutting end that is deep enough to permitthe engaging end of anvil 200 d′ to extend into recess 428 so that anvil200 d′ may be centered and seated. Accordingly, the cutting end ispreferably adapted to receive a portion of the engaging end into thecutter to enable the engaging end to self center and be seated. Also,the engaging end is preferably convex and more preferably spherical.

As shown in FIG. 6C, cutter 400 is spring biased by a spring biasingdevice 450 that is described in detail below in the External AnastomosisOperator section. However, to appreciate the benefits of spring biasedcutting it should be understood that distal end 418 of cutter 400 isreceived into a moveable cutter cup 458 which can push against spring460. The pressure of spring 460 against cutter cup 458 enables cutter400 to apply pressure against anvil 210 as anvil 210 is pulled againstcutter 400. This makes it easier to cut the vessels as force is beingapplied in both directions. More particularly, it reduces the amount offorce that would otherwise be required if the only force being appliedwas through the advancement of anvil 210 by pulling anvil pull.

A spring biased cutter also enables the cutter to be pushed back byanvil 210 to allow anvil 210 to further distend the wall of vessel 20 asshown in FIGS. 4A-4B, FIGS. 6D-6E, FIGS. 12C-12E, FIGS. 15B-15C andFIGS. 16D-16E. As anvil 210 pushes cutter 400 through vessel 20, anvil210 causes cutter 400 to retract, however, increasing resistance isencountered as spring 460 becomes further compressed. So cutter 400applies increasing amounts of pressure to vessel 20 as anvil 210continues to stretch the wall of vessel 20 into compression plateapparatus 300. By optimizing features such as the tension of the springand the length of cutter, vessel 20 is distended far enough intocompression plate apparatus 300 to leave sufficient lengths of thevessel in the compression plate apparatus for capturing in thesubsequent eversion process onto holding tabs 314 a. It has been foundthat about 17-18 lbs or about 20 lbs is generally required to form theanastomosis fenestra.

The gradual increase in pressure also serves to assist a sphericalengaging end 212 of anvil 210 to self center on cutter 400. Since thepressure increases gradually, if anvil 210 is initially misaligned oncutter 400 then the gradual increase in pressure causes the anvil to begradually drawn to center as the spherical engaging end 212 is pulledinto chamber 420 or recess 428 of the cutting device. If pressure isapplied too rapidly, the sharp cutting edge 414 of a cutter such ascutter 400 may dig into anvil 210 before anvil 210 can slide into acentered orientation. Accordingly, the use of a cutter with at least arecess at its cutting end and a spherical engaging end accommodatesimperfections in the alignment of the cutter and the anvil.

FIGS. 14A-14B depict a simple combination of a cutter engaging an anvilas the anvil pull 230′″ is advanced by an anvil pull engager 500′ whichholds and advances anvil pull 230′″. Note that distal end 232 of anvilpull 230 is threaded and anvil pull engager is essentially a wingnutthat is correspondingly threaded. As anvil pull engager 500′ tightensagainst the distal end 418 of cutter 400 then anvil pull 230 pulls anvil200 until cutter 400 is engaged. Of course, an even simpler design isthe manual application of pressure by pulling on anvil pull whilepushing on cutter without an anvil pull engager.

FIG. 14C depicts an anastomosis fenestra formed through the use of acutter such as cutter 400′. Cutter 400′ works in the same way as cutter400 except that anvil 200 b′ has an elliptically shaped engaging end andcutter 400 has an elliptically shaped and angled cutting knife 412′ andcutting edge 414′. Such a combination of an anvil with an ellipticallyshaped engaging end and a mated cutter with an elliptically shaped andangled cutting knife and cutting edge enable anastomosis to be formed asshown in FIG. 14C that involves the nonperpendicular attachment of avessel to a side of another vessel. The configuration of the opening andthe diameter of the opening to be formed depends on factors such aswhether the opening is for a venotomy or an arteriotomy.

After the opening is formed by cutter 400′ then the vessels may bejoined in the same way that a vessel is joined perpendicularly to a sideof another vessel. For example, the portions defining the openings maybe clipped or staples together through the use of a clipping or staplingdevice 800 that delivers clips 800 or staples. If the vessels aremechanically joined through the use of sutures, staples or clips then itmay be desirable to enhance the leak proof character of the anastomosisthrough the use of laser welding with a conventional laser weldingdevice, such as an endoscopic laser welding devices. Similarly, the sealmay be augmented through the appropriate use of biocompatible adhesivesadministered by conventional delivery devices, including endoscopic gluedelivery devices. Additionally, a seal may be formed or strengthened bytechniques such as laser soldering, including chromophore-enhanced lasersoldering, and laser sealing.

FIG. 14D depicts a device identified as cutter 400″ which may be used toform the anastomosis fenestra to permit the angled attachment shown inFIG. 14C. Cutter 400″ has an element 430 that may be embodied by asurgical laser such as a cluster of optical fibers 432 that deliversappropriate radiation. Cutter 400″ also has an applicator 440 fordelivering a fluid 442 such as biocompatible adhesives or glue; solder;biological procoagulant solution; a combination of a chromophore andsolder, and combinations thereof. These materials may be delivered afterthe element 430 has been used or simultaneously depending on theobjective. For example, if fluid 442 is an adhesive then applicator 440can deliver the adhesive in a controlled manner after the radiation hasbeen delivered to ablate the vessel wall to open the anastomosisfenestra. However, when utilizing element 430 for welding radiation orlaser sealing then fluid 442 is preferably delivered before or issimultaneously delivered Also, cutter 400″ may be used only to deliverglue after a mechanical cutter such as cutter 400′ has been used.Adhesives and solder may be used alone, or as discussed above, adhesivesand solder may be utilized to further seal an anastomosis that utilizesa mechanical devices such as clips as shown in FIG. 14C.

External Anastomosis Operators

The positioning of the compression plate apparatus and the operations ofpulling or holding anvil pull 230, making an opening, and compressingthe compression plates together as described in the foregoing sectionscan be accomplished by manually actuating these elements or with the aidof devices such as external anastomosis operator 700. One advantagederived form the use of a device such as external anastomosis operator700 is that such devices have a series of actuators, and by manipulatingthese actuators the operator can effectuate the different operations atthe anastomosis site without actually having to manually and directlyoperate each element itself.

As shown in FIG. 6A, external anastomosis operator 700 has a body 710with an optional handle 720. Attached to body 710, are the maincomponents of operator 700, as identified in FIG. 6A. These maincomponents are cutter 400, spring biasing device 450, an anvil pullengager 500 which includes an anvil pull holder 530 and an anvil pulladvancer 560, and an attachment actuation device 600.

FIG. 6B provides an exploded perspective view of all of the componentsof external anastomosis operator 700 so it is with reference primarilyto this view that the details of operator 700 are understood. FIGS.6C-6E provide cross-sectional views of operator 700 depicting the stepsfor using operator 700.

Cutter 400 is shown in FIG. 6B-E as including a tip portion 401 and anextension portion 402. Note that cutter 400 is shown elsewhere as beingintegral. The advantages of using a spring biasing device 450 to applypressure against the distal end 418 of cutter 400 are explained above inthe Cutting Devices section. However, the components of spring biasingdevice 450 are described in this section.

Spring biasing device 450 has a spring mount 452 that is mounted to body710 via spring mount pins 454. A rotatable spring housing 456 isthreadably engaged by spring mount 452. Loaded into rotatable springhousing 456 is a cutter cup 458 that is configured to hold distal end418 of cutter. Cutter cup 458 has a flange that is pushed against aflange at the proximal end of rotatable spring housing 456 such thatcutter cup 458 is held in the proximal end of spring housing 456. Aspring 460 is positioned within a spring sleeve 462. Spring 460 andspring sleeve 462 have ends that abut cutter cup 458 and opposite endsthat abut threaded jam screw 464. Threaded jam screw 464 is accessiblevia the distal end of spring mount 452 so that it may be rotated toincrease or decrease the tension of spring 460 against cutter cup 458.

Cutter cup 458 moves within rotatable spring housing 456 against spring460. As discussed generally above in the Cutting Devices section, thepressure of spring 460 against cutter cup 458 enables cutter 400 toapply pressure against anvil 210 as anvil 210 is pulled against cutter400. This makes it easier to cut the vessels as force is being appliedin both directions. It also enables cutter 400 to be pushed back byanvil 210 to allow anvil 210 to further distend the wall of vessel 20 asshown in FIGS. 4A-4B until sufficient pressure is applied by spring 460to bias cutter 400 forward and by the advancement of anvil 210 by anvilpull 230 to cut the vessel. The gradual increase in pressure also servesto assist a spherical engaging end 212 of anvil 210 to self center oncutter 400. More particularly, anvil 210 may be initially misalignedsuch that the center of engaging end from which anvil pull extends ispositioned on cutting edge 414. A rapid application of pressure wouldlock such a misalignment while a gradual increase enables the curvatureof spherical engaging end to guide the anvil into a centeredorientation.

Another function of spring biasing device is to set the position ofcutter 400. Rotatable spring housing 456 has a notch 457 at its distalend that enables a screw driver to rotate rotatable spring housing 456within spring mount 452 to advance or retract rotatable spring housing456 within spring mount 452. Movement of rotatable spring housing 456also moves cutter cup 458, thereby determining the location of distalend 418 of cutter 400 within operator 700. Of course advancement ofcutter cup 458 towards the proximal end of operator 700 causes cuttingknife 400 to be engage anvil 210 closer to first compression plate 310 awhile retraction of cutter cup 458 towards the distal end of operator700 causes cutting knife and anvil to engage each other closer to secondcompression plate 310 b. The position of cutter 400 is preferably set toenable vessel 20 to be distended in a manner that is optimal for thensubsequently everting the portion defining the newly formed opening ontoholding tabs 314 a. To carefully identify the length that rotatablespring housing 456 is advanced or retracted, a detent 470 is threadedinto spring mount such that it can contact rotatable spring housing andengage the grooves 471 of rotatable spring housing in a manner thatenables detent 470 to click as each groove is rotated past detent 470.

Obviously spring biasing device 450 has many variables that impact themanner in which cutter 400 is used in combination with externalanastomosis operator 700. Some of these variables include the inherenttension of spring 460, the tension of spring 460 as caused by theposition of threaded jam screw 464 in spring mount 452 against spring460, and the position of the surface which distal end 418 of cutter 400abuts, namely cutter cup 660 as determined by the position of rotatablespring housing 456 within spring mount 452.

Spring biasing device 450 is an example of spring biasing means forproviding tension against the cutting means as the cutting means engagesthe anvil means of the intraluminally directed anvil apparatus. Thespring biasing means provides an amount of tension that enables thecutting means to form the first vessel opening after the wall of thefirst vessel has been distended by the action of the anvil means beingpulled into the openings of the compression plate assembly such thatforming the first vessel opening results in at least partial eversion ofthe portion of the first vessel defining the first vessel opening.

As indicated above, anvil pull engager 500 has two primary componentsincluding an anvil pull holder 530 and anvil pull advancer. Anvil pullholder 530 receives anvil pull 230 via spring biasing device 450. Moreparticularly, anvil pull 230 extends through cutter cup 458, rotatablespring housing 456, spring 460 and sleeve 462 around spring 460, and outof threaded jam screw 464.

Anvil pull holder 530 includes a holder mount 532 positioned in track730 of body 710. In this embodiment, holder mount is moveable so thatthe anvil pull can be advanced after it is held. However, in otherembodiments, the anvil pull holder may just lock the anvil pull intoposition such that the cutter is moved against a stationary anvil.Similarly, the spring biasing device 450 may be eliminated so that thevessel is cut only by pressure exerted by the anvil pull against thecutter. As discussed above, while the cutter and the anvil may engageeach other in these arrangements, it is preferable for the cutter toapply some pressure as the anvil pull is advanced against the cutter.

Holder mount 532 may be utilized in different ways to hold anvil pull230. Holder 530 has a split cone 534 inserted into a tapered chamber 536against a spring 538. Anvil pull 230 extends through apertures in holdermount 532, spring 538, split cone 534 and out of an aperture centered inholder knob 540. Holder knob 540 is threadably engaged by holder mount532 such that rotation of holder knob 540 advances split cone 534 intapered chamber 536 causing split cone to lock onto anvil pull 230. Asshown in FIG. 6B, holder mount is slotted at its distal end as is holderknob. By aligning slot 542 of holder knob 540 with the insert slot 544of holder mount, anvil pull 230 can be bent so that it extends throughboth holder knob slot 542 and insert slot 544. Then holder knob 540 canthen be rotated so that the bent portion of anvil pull 230 is rotatedinto one of the locking slots 546 a-b that extend perpendicularly frominsert slot 544. This securely locks anvil pull into position. Anvilpull 230 can be locked through the use of slots instead of or inaddition to the use of split cone 534 in tapered chamber 536.

The anvil pull holders described herein are examples of holding meansfor holding the anvil pull extending from an anvil. The anvil pulladvancers described herein are examples of advancement means for pullingthe anvil pull once the anvil pull is held by the holding means. Asindicated above, the anvil pull holder may have a fixed position suchthat it is not moveable. As also indicated above, however, the anvilpull holder is preferably moved via an anvil pull advancer. A fixedanvil pull holder and an anvil pull holder that is moveable via an anvilpull advancer are both examples of an anvil pull engagers. The anvilpull holder and the anvil pull advancer may be separate components suchas anvil pull holder 530 and anvil pull advancer 560 or be embodied by acomponent capable of both holding and advancing the anvil pull such asanvil pull engager 500′ shown in FIGS. 14A-14B. These anvil pullengagers are all examples of engaging means for holding an anvil pullextending from an anvil. Once such engaging means holds the anvil pullthen the engaging means can control the position of the anvil at theanastomosis site via the anvil pull.

Since anvil pull holder 530 is moveable it threadably engages rotatablelead screw 562 of anvil pull advancer. More particularly, lead screw 562is threadably engaged by antibacklash nut 550 which is fixedly attachedto holder mount 532. Anti-backlash nut 550 has an attachment face 552through which a plurality of attachment face screws 554 extend to holdholder mount 532 and anti-backlash nut 550 together.

Lead screw 562 has a proximal pivot end 564 that rotates within abushing 566 positioned within a recess in spring mount 452. Lead screwalso has a distal pivot end 568 that is attached to advancer knob 570 torotate lead screw 562. Advancer knob 570 rotates within an advancer knobmount 572 which is attached to body 710 in groove 730 via advancer knobmount bolts 574. As shown in FIG. 6C, distal pivot end 568 rotates in abushing 576 positioned within an aperture of advancer knob mount 572.

Advancer knob 570 has a stem with a plurality of grooves 578 that engagea detent 580 to click so that the incremental rotation of advancer knob570 can be carefully counted to determine the length that the anvil ismoved in the compression plate apparatus as the anvil pull is advanced.As shown in FIG. 6C, detent 580 is threaded into advancer knob mount 572such that it can contact grooves 578 in the stem of advancer knob 570 toclick as each groove is rotated past detent 580.

FIG. 6D depicts advancer knob 570 being rotated to move anvil pulladvancer 560 so that it can urge anvil pull 230 in a manner such thatanvil 210 is advanced within compression plate apparatus 300. Asadvancer knob 570 is rotated, lead screw 562 is thereby rotated. Sinceanvil pull holder 530 is threadably engaged on rotatable lead screw 562and is locked in track 730, anvil pull holder 530 can only move forwardand backward as lead screw 562 is rotated.

FIG. 6E depicts attachment actuation device 600 being engaged.Attachment actuation device 600 has a first plate engager 600 a and asecond plate engager 600 b. First plate engager 600 a and a second plateengager 600 b each respectively utilize an optional adaptor 610 a-b toengage first and second compression plates 310 a-b. Note that attachmentactuation device 600′ described in reference to FIGS. 12CA-12G does notutilize these optional adapters since its first and second plateengagers 600 a′-600 b′ adapted to directly engage first and secondcompression plates 310 a′-310 b′.

First plate engager 600 a and second plate engager 600 b each have acutter aperture 620 a and 620 b. Cutter 400 extends through thesealigned apertures 620 a-b. First plate engager 600 a is positioned onrail 640 such that it extends slightly beyond cutting edge 414 of cutter400. This difference in length enables first compression plate 300 a tobe held slightly beyond cutter in a manner that permits the wall ofvessel 20 to be pulled into compression plate apparatus as shown in FIG.6D-6E and distended as needed.

Rail 640 is attached to body 710 via rail pin 642. A groove pin 644extends through rail 640 as described in greater detail below. A firstplate engager pin 646 holds first plate holder 600 a on the proximal endof rail 640.

First plate engager 600 a is fixedly mounted on rail 640 via pin 646while second plate engager 600 b is movably mounted on rail 640. Secondplate engager 600 b has a groove 634 through which groove pin 644extends. The configuration of groove pin 644 in groove 634 enablessecond plate engager 600 b to be held in a fixed orientation such thatit can be moved back and forth as needed with respect to first plateengager 600 a.

Second plate engager is moved on rail 640 by rotating threadedcompressor sleeve 650 which engages a threaded rail sleeve 648. Threadedrail sleeve 648 may be adhered onto rail 640 or be an integralcomponent. Rail 640 and its threaded rail sleeve 648 or threaded railportion combined with compressor sleeve 650 are means for advancing oneplate engager towards the other plate engager.

First plate engager 600 a has an adaptor 610 a that preferably has twohalves 612 a and 614 a. As best seen in FIG. 6C, when these halves arejoined together, adaptor 610 a has a proximal side configured such thatthere is a curvature from the perimeter inward to direct the engagingend 212 of anvil 210 into the aperture defined by the inner perimeter ofadaptor 610 a. The distal side of adaptor 610 a has a recess 616 adaptedto the size of outer periphery 311 a of first compression plate 310 a.Sets screws 615 lock first compression plate 310 a in place by pushingagainst adaptor 610 a. Note that there are many other ways for lockingfirst compression plate with first plate engager 600 a such as the useof conventional quick release configurations.

Second plate engager 600 b has an adaptor 610 b or 610 b as respectivelyshown in FIGS. 5A-5B. Adapter 610 b is integral while adapter 610 b′ hashalves 612 b and 614 b. Either may be utilized, but when positioned on agraft vessel as shown in FIG. 5B that has reinforcements 57, which maybe any conventional reinforcements such as fluorinatedethylene-propylene (FEP) strands bonded onto a PTFE graft vessel, thereinforcements make it difficult to remove the adapter that it integrallike adaptor 610 b. As best seen in FIG. 5A, adaptor 610 b is tubular toreceive the vessel and has a flange 616 b that extends around the tubeand is sized to push against exterior side 324 b of second compressionplate 310 b. Apertures 618 b are located in flange 616 b that areoriented and sized to slidably receive guides 330 of compression plateapparatus 300. Adapter 610 b also has a flange with apertures so that itcan fit over second compression plate 310 b as shown in FIG. 5B. Thesefeatures are more clearly shown in FIG. 6C which provides across-sectional view of assembly 390 shown in FIG. in FIG. 5B. Note thatadaptor 610 b is also shown in FIG. 16C, which is a close-up view of theproximal portion of applicator 700, however, adaptor 610 b is pushedback from its position of engagement with second compression plate 310 bin order to more clearly see other features of operator 700.

As discussed below in the Side-to-Side Anastomosis section in referenceto FIG. 15A-15C, the attachment actuation device need not be part of thesame apparatus with the anvil pull engager and the cutter. FIGS. 15A-15Cshow a device at 600 a″ that is adapted to hold the first compressionplate stationary as the anvil and the cutter are engaged. Device 600″ isalso discussed below in reference to FIGS. 15A-15C which is used toapproximate compression plates 310 a-b by pushing second compressionplate 310 b on guides 330. Attachment actuation device 600, 600′ and600′″ are examples of attachment actuation means for actuating acompression plate assembly. In addition to device 600, 600′, and 600′″,device 600 a″ is also an example of an attachment actuation deviceadapted to hold the first compression plate stationary as the anvil andcutting device are engaged to form an opening.

As noted above, compression plate apparatus 300, 300′, 300″ are examplesof means for joining a portion of the first vessel that defines thefirst vessel opening to a portion of a second vessel that defines asecond vessel opening. Accordingly, attachment actuation device 600 ismore broadly an example of attachment actuation means for actuatingmeans for joining a portion of the first vessel that defines the firstvessel opening to a portion of a second vessel that defines a secondvessel opening.

Other examples of attachment actuation means include mechanical,chemical or radiation-based attachment actuation means for actuating theanastomosis of the portion of the first vessel that defines the firstvessel opening to the portion of the second vessel that defines thesecond vessel opening. Examples of mechanical attachment actuation meansinclude a suturing device such as a needle and thread; and a stapling orclipping device such as device 800. Examples of chemical attachmentactuation means include a device such as device 400″ for deliveringbiocompatible adhesives or glue; solder; biological procoagulantsolution; a combination of a chromophore and solder, and combinationsthereof. Examples of radiation-based attachment actuation means includea device such as device 400″ for radiation welding, a device for lasersealing, and combinations thereof. As shown by device 400 and 800,combinations of these attachment actuation means are also possible.

As mentioned, the attachment actuation device need not be part of thesame apparatus with the anvil pull engager and the cutter. This reducesthe size of the instruments utilized. The size of the instrumentsutilized may also be decreased through the elimination of some of thefeatures of operator 700. Operator 700 has the ability to modify itsconfiguration in ways that enable it to be highly fine tuned to theparameters of a particular anastomosis procedure. Accordingly, it ishighly useful in a research setting. However, applicators utilized in acommercial setting may have more standardized features that do notpermit the same degree of modifications. For example, the spring biasingdevice may be preset to a standard setting. Use of such standardsettings may assist in reducing the overall size of the operator. Notethat the knobs and other features of external anastomosis operator thatprovide adjustments may also be achieved through other configurationsthat achieve these adjustments more rapidly. For example, instead ofrotating compressor sleeve 650, compression plate apparatus 300 may becompressed through a configuration that is trigger activated.

As indicated above, anvil 210 may be positioned under direct imageguidance from a distant percutaneous puncture to the anastomosis sitebased upon a diagnostic angiographic s roadmap. A skin incision andlimited vessel dissection is then performed at the anastomosis site toexpose the vessel wall. Alternatively, the anvil may be externallypositioned. In either event, once the anvil has been positioned suchthat it is against the interior of the vessel wall and the anvil pullextends from the vessel, then the anvil pull can be positioned in theoperator 700 as shown in FIGS. 6C-6D for completion of the anastomosisprocedure.

Side-to-Side Anastomosis

FIGS. 15A-15C depict the primary steps involved in achieving aside-to-side anastomosis. Cutter 400 is positioned in a vessel 50 byinserting the cutter into an end of vessel 50 and then twisting cutter400 in vessel 50 such that cutting knife 412 is oriented towards thewall of vessel 50 as shown in FIG. 15A. Cutting knife 412 is preventedfrom cutting through the wall of vessel 50 by a sheath 490. Sheath 490is positioned relative to cutter 400 such that the distal end 492 ofsheath 490 extends beyond cutting edge 414. This configuration preventcutting edge 414 from contacting vessel 50 until sheath 490 is pulledupward away from the anastomosis site.

Two separate instruments perform the task of attachment actuation device600. First plate engager 600 a″ comprises tongs or pliers that haveopposing grasping portion 602 a″ that extend integrally from pivotallyattached handle portions 604 a″. Grasping portions 602 a″ are adapted tolock onto first compression plate 310 a so that anvil 210 can be pulledthrough first compression plate opening 320 a and distend the wall ofvessel 20 into compression plate apparatus 300.

While first plate engager 600 a″, holds first compression plate 310 acutter 400, sheath 490 and vessel 50 are pushed through secondcompression plate opening 320 b. Note that anvil pull 230 extendsthrough the wall of vessel 50 and through chamber 420 of cutter 400. Ascutter 400 is pushed through compression plate apparatus 300 andcontacts anvil 230, sheath 490 is retracted.

FIG. 15B shows sheath 490 retracted so that cutter 400 and anvil 210 canengage each other such that openings 24 and 54 are simultaneously maderespectively in vessel 20 and in vessel 50. After opening 54 is made,the portion 56 defining second vessel opening 54 rests on either sheath490, cutting tube 410 or anvil 210. As the compression plates arebrought together, portion 56 is advanced onto landing 214 againstportion 26 of vessel 20 that defines first vessel opening 24.

FIG. 15B shows first and second compression plate apparatus beinggrasped by attachment actuation device 600′″. More particularly,attachment actuation device 600′″ has a first plate engager 600 a′″ thatengages first compression plate 310 a and a second plate engager 600 b′″that engages first compression plate 310 b such that the compressionplates 310 a-b can be approximated by pushing second compression plate310 b on guides 330.

FIG. 15C depicts attachment actuation device 600′″ after it has pushedsecond compression plate 310 b to first compression plate 310 a. Assecond compression plate 310 b is pushed toward first compression plate310 a, portion 56 of vessel 50 pushes against portion 26 of vessel 20 asthese portions rest on landing 214 which causes the portions torespectively curl onto holding tabs 314 a-b. When the second compressionplate 310 b is fully pushed into position by attachment actuation device600′″ then portions 26 and 56 are everted as shown on holding tabs 314a-b. Cut portions 25 and 55 remain on spherical engaging end 212 ofanvil 210 and are removed with anvil apparatus 200, cutter 400 andsheath 490 through vessel 50.

It follows from the illustrations and the foregoing discussion that thecompression plates of this invention can effectively be used foranastomoses at the end of tubular structures. This implementation of theteachings described above to end-to-end anastomosis simply requiresordinary skills in the art.

Externally Directed Anastomosis

Intraluminal access to the anastomosis site in the receiving bloodvessel can be impeded by an occlusion or by blood vessel damage. In thiscase, a catheter cannot be used to intraluminally access the anastomosissite. Instead, other embodiments of this invention rely on theintraluminal access to the anastomosis site through a small incision,such as an arteriotomy, made at the anastomosis site. The anvilapparatus is then inserted through such incision and the abutting of thereceiving blood vessel from its intraluminal space is then performed inthe same way as when the anvil and wire are inserted with the aid of acatheter.

FIGS. 16A-16E depict the primary steps involved in creating ananastomosis through the use of an externally positioned anvil apparatusin combination with an external anastomosis operator. FIG. 16A depictsan insertion opening 16 that has been made in vessel 20. Insertionopening 16 is preferably just large enough to permit an anvil such asanvil 210 c as shown in FIG. 7C or any of the other anvils disclosedherein to be externally positioned into lumen 28. After anvil 210 c hasbeen inserted though a wall of first vessel 20 at insertion opening 16that has been selected as an anastomosis site such that anvil pull 230extends through insertion opening 16, then a stay suture 30 or severalstay sutures may alternatively be used to partially close insertionopening 16.

As discussed above, in relation to FIG. 7D, it may be easier to insertan anvil extraluminally that has a tapered terminal end 218 such asterminal end 218 c of anvil 210 c or terminal end 219 c of anvil 210 d.Note that FIGS. 16C-16E, however, show an anvil 210 that has beeninserted from outside of vessel 20 that has a nontapered terminal end218.

As shown in FIG. 16C, anvil pull 230 can then be loaded into externalanastomosis operator 700 for the anastomosis procedure. Note that onceanvil pull 230 is loaded into external anastomosis operator 700 then theremainder of the procedure is the same as the anastomosis procedureoutlined above in reference to an intraluminally positioned anvilapparatus.

FIG. 16D depicts anvil pull 230 extending through compression plateapparatus 300 and into chamber 420 of cutter 400 such that cutting edge414 self centers and seats on spherical engaging end 212 of anvil 210just as is shown in FIG. 4A which depicts the use of an intraluminallypositioned anvil apparatus. The only difference between the FIG. 4A andFIG. 16D is that initial piercing 15 is significantly smaller thaninsertion opening 16. Stay suture 30, however, enables anvil 210 todistend the wall of vessel 20 since stay suture 30 reduces the size ofinsertion opening 16.

FIG. 16E shows that it is possible to complete the same step shown inFIG. 16D without a stay suture 30 as long as the distension of the wallof vessel 20 does not cause insertion opening 16 to increase in sizesuch that it becomes so large that a part of it is beyond the reach ofcutting edge 414 of cutter 400. Accordingly, when distending a vesselthat has an insertion opening 16 from an extraluminally positioned anvilinstead of a relatively small initial piercing 15 from an anvil pull ofan intraluminally directed anvil apparatus, it may not be possible todistend the vessel to the extent that is possible with an intraluminallydirected anvil apparatus. For this reason landing 214 of anvil 210 shownin FIG. 16E is shorter than landing 214 of anvil 210 shown in FIG. 4Aand in FIG. 16E.

Another method for enabling the wall of the vessel to be distended forthe subsequent eversion process to occur in the desired manner involvesthe minimization of the size of insertion opening 16 through the use ofexpandable anvils. As discussed above in the Anvil section, anvils maybe utilized that are expanded or deployed at the anastomosis site. Forexample FIGS. 9A-9B and FIGS. 10A-10B depict mechanically deployableanvils while FIGS. 11A-11B depict chemically deployable anvils. Thesesame expandable anvils may be inserted through a small insertion openingfrom the exterior of the vessel into the lumen and then be deployed.Accordingly, such expandable anvils have an initial collapsed positionfor insertion into the insertion opening and an expanded position. Oncethe anvil has been deployed then it can be used like solid or rigidanvils.

Just like the anvils that are intraluminally directed, anvils that areexternally positioned into the lumen of a vessel preferably have anengaging end that is larger than cutter 400 such that portions of theengaging end 212 of the anvil extend beyond the cutting edge 414 whenthe cutter 400 or other cutting device engages the anvil and forms thefirst vessel opening. Stated otherwise, the cross-sectional area definedby the perimeter of cutting edge 414 of the cutting knife 412 is smallerthan a cross-sectional area of the engaging end 212 at which cuttingedge 414 engages engaging end 212. So for an expandable anvil, itsengaging end preferably has a greater cross-sectional area than thecross-sectional area defined by cutting perimeter of the cutting devicewhen in the expanded position. Also, the engaging end is also sphericalsuch that cutter self seats and self centers on spherical engaging end212. The advantages of these configurations are discussed in detailabove in the Anvils section.

Note that as shown by FIGS. 18A-18B, externally positioned anvils may beused to form noncircular openings. These anvils have an engaging endwith a shape corresponding to that of the cutting edge of a cutter suchthat the first vessel opening is formed as the noncircular cutting edgepresses against the engaging end.

Externally Positioned Anastomosis Fenestra Cutting Apparatus.

As indicated above, the anvil is preferably sized at its engaging end tohave a greater cross-sectional area than a cross-sectional area definedby the perimeter of the cutting edge of the cutting device such thatportions of the engaging end of the anvil extend beyond the cutting edgewhen the cutting device engages the anvil and forms the first vesselopening. This size differential can be utilized in an apparatus adaptedonly to make vessel openings.

FIG. 17A is a perspective view of an externally positioned anastomosisfenestra cutting apparatus 1000 having an anvil 1210 ready for insertionthrough an insertion opening 16 into the lumen of a blood vessel. FIG.17B is a perspective view of cutting apparatus 1000 distending vessel 20and being readied for cutting. FIG. 17C shows the formation of anopening 25 as cylindrical cutting edge 1414 engages spherical engagingend 1212.

Cutting apparatus 1000′ is shown in FIGS. 18A-18B with an ellipticalanvil 1210′ adapted to form elliptical openings in vessel 20 withelliptical cutting device 1400′. Note that FIG. 18A shows cuttingapparatus 1000′ distending the wall of vessel at angle so that the 11elliptical opening formed by a cutting apparatus 1000′ is properlyoriented for a Y-type end-to-side anastomosis. Cutting apparatus 1000′is a simple device that has a stationary cutter that cuts the bloodvessel when the anvil is pulled against the cutter. Note that whileanvil and anvil pull are shown as being integral, the anvil of thecutting apparatus may also be an expandable anvil such as thosediscussed in the section entitled Anvils.

FIGS. 19A-19B provide a cross-sectional views of cutting apparatus 1000which reveal that it is spring biased. Spring biased cutting apparatus1000 has a handle 1010 that includes a stem 1012 and a handle cap 1014.Stem 1012 travels within a chamber as shown by comparing FIGS. 19A-19Bto push against a high tension spring 1016 that pushes against a cutter1400. While cutter 1400 is movable, anvil pull 1230 moves a greaterdistance in order to contact cutter 1400.

A pin 1020 extends through anvil pull 1230 and casing 1022 such thatmovement of grasping handle 1024, which is an integral component ofcasing 1022, also moves anvil pull 1230. Pin 1020 travels within agroove 1018 as shown in phantom lines in FIGS. 17A-17B. The distal endof anvil pull 1230 abuts a low tension spring 1026 concentricallypositioned within high tension spring 1016. This configuration enablesanvil pull 1230 and cutter 1400 to both be spring biased.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A compression plate anastomosis system, comprising: an anvilapparatus comprising an anvil comprising a landing between an engagingend and a terminal end, and an anvil pull extending from the engagingend of the anvil and configured to control the movement of the anvil; acompression plate apparatus comprising a first compression platecomprising a first ring and a first plurality of holding tabs extendingfrom the first ring, wherein said first plurality of holding tabsdefines a first compression plate opening; and a second compressionplate having a second compression plate opening; wherein the engagingend and the landing of the anvil are sized for movement within the firstcompression plate opening in a manner that permits a part of a wall of afirst vessel at an anastomosis site to be held between the landing ofthe anvil and the first plurality of holding tabs of the firstcompression plate without penetration of the held part; wherein thelanding and the first plurality of holding tabs are sized relative toeach other such that the landing is sufficiently longer than the lengthof the first plurality of holding tabs to permit at least a portion of aregion of the wall of the first vessel extending beyond the part heldbetween the landing of the anvil and the first plurality of holding tabsto rest on the landing of the anvil after formation of an anastomosisopening in the first vessel; wherein the landing of the anvil and thefirst plurality of holding tabs are sized to permit the part of the wallof the first vessel held between the landing of the anvil and the firstplurality of holding tabs of the first compression plate to be held withsufficient force to prevent movement of the held part as the firstvessel portion is moved on the landing by the second compression platesuch that the first vessel portion becomes at least partially evertedover the first plurality of holding tabs of the first compression plate.2. The compression plate anastomosis system as recited in claim 1,wherein the landing of said anvil is cylindrical.
 3. The compressionplate anastomosis system as recited in claim 1, wherein the engaging endof said anvil is flat.
 4. The compression plate anastomosis system asrecited in claim 1, wherein the engaging end of said anvil means isconvex.
 5. The compression plate anastomosis system as recited in claim1, wherein each holding tab of the first plurality of holding tabsextends nonperpendicularly from the first ring.
 6. The compression plateanastomosis system as recited in claim 1, wherein each holding tabterminates at a rounded tip.
 7. The compression plate anastomosisapparatus system as recited in claim 1, wherein the first compressionplate and the second compression plate have mated locking components tolock the compression plates together such that the first vessel portionis held between the first plurality of holding tabs and a secondplurality of holding tabs, which extend from a second ring of the secondanastomosis plate, without being penetrated.
 8. The compression plateanastomosis apparatus system as recited in claim 1, wherein the firstcompression plate opening and the second compression plate opening aregenerally circular.
 9. The compression plate anastomosis apparatussystem as recited in claim 1, wherein the first compression plateopening and the second compression plate opening are noncircular. 10.The compression plate anastomosis system as recited in claim 1, whereinthe first and second compression plates each have locking componentsthat lock into place when the compression plates are brought together.11. The compression plate anastomosis system as recited in claim 7,wherein the first plurality of holding tabs and the second plurality ofholding tabs are in a mated configuration when the first vessel portionis held between the first plurality of holding tabs and the secondplurality of holding tabs.
 12. A compression plate anastomosis system,comprising: an anvil apparatus comprising an anvil comprising a landingbetween an engaging end and a terminal end; a component extending fromthe anvil and configured to control the movement of the anvil; acompression plate apparatus comprising a first compression platecomprising a first ring and a first plurality of holding tabs extendingfrom the first ring, wherein said first plurality of holding tabsdefines a first compression plate opening; wherein the engaging end andthe landing of the anvil are sized for movement within the firstcompression plate opening in a manner that permits a part of a wall of avessel at an anastomosis site to be held between the landing of theanvil and the first plurality of holding tabs of the first compressionplate without penetration of the held part; wherein the landing and thefirst plurality of holding tabs are sized relative to each other suchthat the landing is sufficiently longer than the length of the firstplurality of holding tabs to permit at least a portion of a region ofthe wall of the vessel extending beyond the part held between thelanding of the anvil and the first plurality of holding tabs to rest onthe landing of the anvil.
 13. The system as recited in claim 12, whereinthe engaging end of the anvil is flat.
 14. The system as recited inclaim 12, wherein the engaging end of the anvil is convex.
 15. Thesystem as recited in claim 12, wherein the landing of the anvil iscylindrical.
 16. The system as recited in claim 12, wherein each holdingtab of the first plurality of holding tabs extends nonperpendicularlyfrom the first ring.
 17. The system as recited in claim 12, wherein eachholding tab terminates at a rounded tip.
 18. A compression plateanastomosis system, comprising: an anvil apparatus comprising an anvilcomprising a landing between an engaging end and a terminal end; acomponent extending from the anvil and configured to control themovement of the anvil; a cutting device; and a compression plateapparatus comprising a first compression plate comprising a first ringand a first plurality of holding tabs extending from the first ring,wherein said first plurality of holding tabs defines a first compressionplate opening having a perimeter; a second compression plate having asecond compression plate opening; wherein the engaging end and thelanding of the anvil are sized for movement within the first compressionplate opening in a manner that permits a part of a wall of a vessel atan anastomosis site to be held between the landing of the anvil and thefirst plurality of holding tabs of the first compression plate withoutpenetration of the held part; wherein the landing and the firstplurality of holding tabs are sized relative to each other such that thelanding is sufficiently longer than the length of the first plurality ofholding tabs to permit at least a portion of a region of the wall of thevessel extending beyond the part held between the landing of the anviland the first plurality of holding tabs to rest on the landing of theanvil after formation of an anastomosis opening in the vessel throughengagement of the cutting device and the engaging end of the anvil; andwherein the landing of the anvil and the first compression plate openingare sized to permit the part of the wall of the vessel held between thelanding of the anvil and the first plurality of holding tabs of thefirst compression plate to be held with sufficient force to preventmovement of the held part as the vessel portion is cut throughengagement of the cutting device and the engaging end of the anvil. 19.The system as recited in claim 18, wherein the engaging end of the anvilis flat.
 20. The system as recited in claim 18, wherein the engaging endof the anvil is convex.
 21. The system as recited in claim 18, whereinthe landing of the anvil is cylindrical.
 22. The system as recited inclaim 18, wherein each holding tab of the first plurality of holdingtabs extends nonperpendicularly from the first ring.
 23. The system asrecited in claim 18, wherein each holding tab terminates at a roundedtip.
 24. The system as recited in claim 18, wherein the cutting deviceis a cutter.
 25. The system as recited in claim 18, wherein the cuttingdevice comprises a cutting knife with a cutting edge, and wherein theanastomosis opening is formed as the cutting edge engages the engagingend of the anvil at a location with a perimeter that is larger than theperimeter of the cutting edge.
 26. The system as recited in claim 18,wherein the cutting device comprises a cutting knife with a cuttingedge, and wherein the perimeter of the cutting edge is circular suchthat the perimeter of the anastomosis opening is circular.
 27. Thesystem as recited in claim 18, wherein an anvil pull extends from theanvil and through a piercing located in the extended region of the wallbefore forming the anastomosis opening; and wherein the anvil pull iscoaxially positioned in the cutting device.
 28. The system as recited inclaim 18, wherein the landing of the anvil and the first compressionplate opening are sized to permit the part of the wall of the vesselheld between the landing of the anvil and the first plurality of holdingtabs of the first compression plate to be held with sufficient force toprevent movement of the held part as the anvil is removed from theanastomosis site by moving the anvil through the first compression plateopening of the first compression plate and then through the secondcompression plate opening.
 29. The system as recited in claim 28,wherein removing the anvil from the anastomosis site by moving the anvilthrough the first compression plate opening of the first compressionplate and then through the second compression plate opening removes acut portion of the vessel portion formed through engagement of thecutting device and the engaging end of the anvil.